Recall events
/
Event 82851
Event summary
Timeline bucket May 13, 2019
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Becton Dickinson & Company
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
8 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 8
BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
Z-0054-2020
Recall number Z-0054-2020
Initiated May 13, 2019
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0054-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39457]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
Code information Lot Number/UDI: 8117750 (01)30382903659631 (17)191031(10)8117750(30)50 (17)191031(10)8117750(30)200 (01)50382903659635 8155792 (01)30382903659631 (17)191130(10)8155792(30)50 (17)191130(10)8155792(30)200 (01)50382903659635 8223778 (01)30382903659631 (17)200131(10)8223778(30)50 (17)200131(10)8223778(30)200 (01)50382903659635 8223779 (01)30382903659631 (17)200131(10)8223779(30)50 (17)200131(10)8223779(30)200 (01)50382903659635 8268514 (01)30382903659631 (17)200229(10)8268514(30)50 (17)200229(10)8268514(30)200 (01)50382903659635
Distribution pattern Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[29931]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 8
BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
Z-0055-2020
Recall number Z-0055-2020
Initiated May 13, 2019
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0055-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39454]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
Code information Lot Number/UDI: 811767N (01)30382903659655 (17)190930(10)811767N(30)50 (17)190930(10)811767N(30)200 (01)50382903659659 2019-09-30 815066N (01)30382903659655 (17)191130(10)815066N(30)50 (17)191130(10)815066N(30)200 (01)50382903659659 821471N (01)30382903659655 (17)200131(10)821471N(30)50 (17)200131(10)821471N(30)200 (01)50382903659659 821990N (01)30382903659655 (17)200131(10)821990N(30)50 (17)200131(10)821990N(30)200 (01)50382903659659
Distribution pattern Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[30133]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 8
BD Microtainer SST Part/Catalog No.365967
Z-0056-2020
Recall number Z-0056-2020
Initiated May 13, 2019
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0056-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33151]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
Code information Lot Number/UDI: 8094573 (01)30382903659679 (17)190630(10)8094573(30)50 (17)190630(10)8094573(30)200 (01)50382903659673 8094575 (01)30382903659679 (17)190630(10)8094575(30)50 (17)190630(10)8094575(30)200 (01)50382903659673 8094578 (01)30382903659679 (17)190630(10)8094578(30)50 (17)190630(10)8094578(30)200 (01)50382903659673 8117697 (01)30382903659679 (17)190731(10)8117697(30)50 (17)190731(10)8117697(30)200 (01)50382903659673 8165883 (01)30382903659679 (17)190831(10)8165883(30)50 (17)190831(10)8165883(30)200 (01)50382903659673 8165884 (01)30382903659679 (17)190831(10)8165884(30)50 (17)190831(10)8165884(30)200 (01)50382903659673 8170911 (01)30382903659679 (17)190831(10)8170911(30)50 (17)190831(10)8170911(30)200 (01)50382903659673 8171861 (01)30382903659679 (17)190831(10)8171861(30)50 (17)190831(10)8171861(30)200 (01)50382903659673 8220937 (01)30382903659679 (17)191031(10)8220937(30)50 (17)191031(10)8220937(30)200 (01)50382903659673 8220938 (01)30382903659679 (17)191031(10)8220938(30)50 (17)191031(10)8220938(30)200 (01)50382903659673 8282848 (01)30382903659679 (17)191231(10)8282848(30)50 (17)191231(10)8282848(30)200 (01)50382903659673 8284571 (01)30382903659679 (17)191231(10)8284571(30)50 (17)191231(10)8284571(30)200 (01)50382903659673 8284574 (01)30382903659679 (17)191231(10)8284574(30)50 (17)191231(10)8284574(30)200 (01)50382903659673
Distribution pattern Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[29763]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 8
BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
Z-0057-2020
Recall number Z-0057-2020
Initiated May 13, 2019
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0057-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39453]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
Code information Lot Number/UDI: 8101695 (01)30382903659747 (17)190930(10)8081695(30)50 (17)190930(10)8101695(30)200(01)50382903659741 8101696 (01)30382903659747 (17)190930(10)8081696(30)50 (17)190930(10)8101696(30)200(01)50382903659741 8101699 (01)30382903659747 (17)190930(10)8101699(30)50 (17)190930(10)8101699(30)200(01)50382903659741 8101701 (01)30382903659747 (17)190930(10)8101701(30)50 (17)190930(10)8101701(30)200(01)50382903659741 8106835 (01)30382903659747 (17)190930(10)8106835(30)50 (17)190930(10)8106835(30)200(01)50382903659741 8106837 (01)30382903659747 (17)190930(10)8106837(30)50 (17)190930(10)8106837(30)200(01)50382903659741 8106842 (01)30382903659747 (17)190930(10)8106842(30)50 (17)190930(10)8106842(30)200(01)50382903659741 8106847 (01)30382903659747 (17)190930(10)8106847(30)50 (17)190930(10)8106847(30)200(01)50382903659741 8106850 (01)30382903659747 (17)190930(10)8106850(30)50 (17)190930(10)8106850(30)200(01)50382903659741 8120851 (01)30382903659747 (17)191031(10)8120850(30)50 (17)191031(10)8120850(30)200(01)50382903659741 8121979 (01)30382903659747 (17)191031(10)8121979(30)50 (17)191031(10)8121979(30)200(01)50382903659741 8121981 (01)30382903659747 (17)191031(10)8121981(30)50 (17)191031(10)8121981(30)200(01)50382903659741 8124783 (01)30382903659747 (17)191031(10)8124783(30)50 (17)191031(10)8124783(30)200(01)50382903659741 8124880 (01)30382903659747 (17)191031(10)8124880(30)50 (17)191031(10)8124880(30)200(01)50382903659741 8127770 (01)30382903659747 (17)191031(10)8127770(30)50 (17)191031(10)8127770(30)200(01)50382903659741 8128575 (01)30382903659747 (17)191031(10)8128575(30)50 (17)191031(10)8128575(30)200(01)50382903659741 8129642 (01)30382903659747 (17)191031(10)8129642(30)50 (17)191031(10)8129642(30)200(01)50382903659741 8129645 (01)30382903659747 (17)191031(10)8129645(30)50 (17)191031(10)8129645(30)200(01)50382903659741 8197705 (01)30382903659747 (17)191231(10)8197705(30)50 (17)191231(10)8197705(30)200(01)50382903659741 8197970 (01)30382903659747 (17)191231(10)8197970(30)50 (17)191231(10)8197970(30)200(01)50382903659741 8198921 (01)30382903659747 (17)191231(10)8198921(30)50 (17)191231(10)8198921(30)200(01)50382903659741 8198927 (01)30382903659747 (17)191231(10)8198927(30)50 (17)191231(10)8198927(30)200(01)50382903659741 8243545 (01)30382903659747 (17)200229(10)8243545(30)50 (17)200229(10)8243545(30)200(01)50382903659741 8247628 (01)30382903659747 (17)200229(10)8247628(30)50 (17)200229(10)8247628(30)200(01)50382903659741 8248705 (01)30382903659747 (17)200229(10)8248705(30)50 (17)200229(10)8248705(30)200(01)50382903659741 8249986 (01)30382903659747 (17)200229(10)8249986(30)50 (17)200229(10)8249986(30)200(01)50382903659741 8288904 (01)30382903659747 (17)200331(10)8288904(30)50 (17)200331(10)8288904(30)200(01)50382903659741 8290928 (01)30382903659747 (17)200331(10)8290928(30)50 (17)200331(10)8290928(30)200(01)50382903659741"
Distribution pattern Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[30151]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 8
BD Microtainer SST- Amber Part/Catalog Number: 365978
Z-0058-2020
Recall number Z-0058-2020
Initiated May 13, 2019
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0058-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33152]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
Code information Lot Number/UDI: 8193502 (01)30382903659785 (17)190930(10)8193502(30)50 (17)190930(10)8193502(30)200(01)50382903659789 8193507 (01)30382903659785 (17)190930(10)8193507(30)50 (17)190930(10)8193507(30)200(01)50382903659789 8193511 (01)30382903659785 (17)190930(10)8193511(30)50 (17)190930(10)8193511(30)200(01)50382903659789 8204927 (01)30382903659785 (17)190930(10)8204927(30)50 (17)190930(10)8204927(30)200(01)50382903659789 8205758 (01)30382903659785 (17)190930(10)8205758(30)50 (17)190930(10)8205758(30)200(01)50382903659789 8207774 (01)30382903659785 (17)190930(10)8207774(30)50 (17)190930(10)8207774(30)200(01)50382903659789 8208542 (01)30382903659785 (17)190930(10)8208542(30)50 (17)190930(10)8208542(30)200(01)50382903659789 8208544 (01)30382903659785 (17)190930(10)8208544(30)50 (17)190930(10)8208544(30)200(01)50382903659789 8232513 "(01)30382903659785 (17)191031(10)8232513(30)50 (17)191031(10)8232513(30)200(01)50382903659789 8233967 (01)30382903659785 (17)191031(10)8233967(30)50 (17)191031(10)8236756(30)200(01)50382903659789 8236755 (01)30382903659785 (17)191031(10)8236755(30)50 (17)191031(10)8236755(30)200(01)50382903659789 8236756 (01)30382903659785 (17)191031(10)8236756(30)50 (17)191031(10)8233967(30)200(01)50382903659789 8239857 (01)30382903659785 (17)191031(10)8239857(30)50 (17)191031(10)8239857(30)200(01)50382903659789 8260948 (01)30382903659785 (17)191130(10)8260948(30)50 (17)191130(10)8260948(30)200(01)50382903659789 8262866 (01)30382903659785 (17)191130(10)8262866(30)50 (17)191130(10)8262866(30)200(01)50382903659789 8282812 (01)30382903659792 (17)191231(10)8282812(30)50 (17)191231(10)8282812(30)200(01)50382903659796"
Distribution pattern Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[29958]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 8
BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
Z-0059-2020
Recall number Z-0059-2020
Initiated May 13, 2019
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0059-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39460]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
Code information Lot Number/UDI: 808592N (01)30382903659853 (17)190630(10)808592N(30)50 (17)190630(10)808592N(30)200(01)50382903659857 809669N (01)30382903659853 (17)190630(10)809669N(30)50 (17)190630(10)809669N(30)200(01)50382903659857 811070N (01)30382903659853 (17)190630(10)811070N(30)50 (17)190630(10)811070N(30)200(01)50382903659857 811071N (01)30382903659853 (17)190630(10)811071N(30)50 (17)190630(10)811071N(30)200(01)50382903659857 811664N (01)30382903659853 (17)190630(10)811664N(30)50 (17)190630(10)811664N(30)200(01)50382903659857 813767N (01)30382903659853 (17)190731(10)813767N(30)50 (17)190731(10)813767N(30)200(01)50382903659857 815060N (01)30382903659853 (17)190731(10)815060N(30)50 (17)190731(10)815060N(30)200(01)50382903659857 815061N (01)30382903659853 (17)190831(10)815061N(30)50 (17)190831(10)815061N(30)200(01)50382903659857 815062N (01)30382903659853 (17)190831(10)815062N(30)50 (17)190831(10)815062N(30)200(01)50382903659857 816499N (01)30382903659853 (17)190831(10)816499N(30)50 (17)190831(10)816499N(30)200(01)50382903659857 821563N (01)30382903659853 (17)191031(10)821563N(30)50 (17)191031(10)821563N(30)200(01)50382903659857 821564N (01)30382903659853 (17)191031(10)821564N(30)50 (17)191031(10)821564N(30)200(01)50382903659857 821565N (01)30382903659853 (17)191031(10)821565N(30)50 (17)191031(10)821565N(30)200(01)50382903659857 821888N (01)30382903659853 (17)191031(10)821888N(30)50 (17)191031(10)821888N(30)200(01)50382903659857 827063N (01)30382903659853 (17)191231(10)827063N(30)50 (17)191231(10)827063N(30)200(01)50382903659857 827064N (01)30382903659853 (17)191231(10)827064N(30)50 (17)191231(10)827064N(30)200(01)50382903659857 827589N (01)30382903659853 (17)191231(10)827589N(30)50 (17)191231(10)827589N(30)200(01)50382903659857 827693N (01)30382903659853 (17)191231(10)827693N(30)50 (17)191231(10)827693N(30)200(01)50382903659857 827699N (01)30382903659853 (17)191231(10)827699N(30)50 (17)191231(10)827699N(30)200(01)50382903659857"
Distribution pattern Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[29367]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 8
BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
Z-0060-2020
Recall number Z-0060-2020
Initiated May 13, 2019
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0060-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21691]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
Code information Lot Number/UDI: 819352N (01)30382903659877 (17)190930(10)819352N(30)50 (17)190930(10)819352N(30)200(01)50382903659871 822851N (01)30382903659877 (17)191031(10)822851N(30)50 (17)191031(10)822851N(30)200(01)50382903659871 822852N (01)30382903659877 (17)191031(10)822852N(30)50 (17)191031(10)822852N(30)200(01)50382903659871 822853N (01)30382903659877 (17)191031(10)822853N(30)50 (17)191031(10)822853N(30)200(01)50382903659871 822854N (01)30382903659877 (17)191031(10)822854N(30)50 (17)191031(10)822854N(30)200(01)50382903659871 822855N (01)30382903659877 (17)191031(10)822855N(30)50 (17)191031(10)822855N(30)200(01)50382903659871 822862N (01)30382903659877 (17)191031(10)822862N(30)50 (17)191031(10)822862N(30)200(01)50382903659871 824092N (01)30382903659877 (17)191031(10)824092N(30)50 (17)191031(10)824092N(30)200(01)50382903659871 826768N (01)30382903659877 (17)191130(10)826768N(30)50 (17)191130(10)826768N(30)200(01)50382903659871 827652N (01)30382903659877 (17)191231(10)827652N(30)50 (17)191231(10)827652N(30)200(01)50382903659871 827753N (01)30382903659877 (17)191231(10)827753N(30)50 (17)191231(10)827753N(30)200(01)50382903659871 827754N (01)30382903659877 (17)191231(10)827754N(30)50 (17)191231(10)827754N(30)200(01)50382903659871
Distribution pattern Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[29648]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 8
BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992
Z-0061-2020
Recall number Z-0061-2020
Initiated May 13, 2019
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0061-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39456]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
Code information Lot Number/UDI: 8212777 (01)30382903659921 (17)191031(10)8212777(30)50 (17)191031(10)8212777(30)200(01)50382903659925 8212785 (01)30382903659921 (17)191031(10)8212785(30)50 (17)191031(10)8212785(30)200(01)50382903659925 8268546 (01)30382903659921 (17)191130(10)8268546(30)50 (17)191031(10)8268546(30)200(01)50382903659925 8268549 "(01)30382903659921 (17)191130(10)8268549(30)50 (17)191130(10)8268549(30)200(01)50382903659925
Distribution pattern Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[30140]
FDA event record
· Exact recall-number query on openFDA
