Recall events
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Event 80954
Event summary
Timeline bucket July 24, 2018
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Siemens Healthcare Diagnostics, Inc
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
5 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 5
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Z-0113-2019
Recall number Z-0113-2019
Initiated July 24, 2018
Classification Class II
Status Terminated
Quantity 1870 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
A potential bias was identified with certain kits compared to the internal standards.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0113-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15497]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall A potential bias was identified with certain kits compared to the internal standards.
Code information SMN 10311570 Lot # Expiry UDI # 57834A64 2018-Dec-11 (01)00630414124803(10)57834A64(17)20181211 57835A64 2018-Dec-11 (01)00630414124803(10)57835A64(17)20181211 72519A64 2018-Dec-11 (01)00630414124803(10)72519A64(17)20181211 98115A64 2018-Dec-11 (01)00630414124803(10)98115A64(17)20181211
Distribution pattern US Nationwide Distribution
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[27995]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 5
ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Z-0114-2019
Recall number Z-0114-2019
Initiated July 24, 2018
Classification Class II
Status Terminated
Quantity 69 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
A potential bias was identified with certain kits compared to the internal standards.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0114-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45649]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall A potential bias was identified with certain kits compared to the internal standards.
Code information SMN 10333512 Lot # Expiry UDI # 58311A67 2018-Dec-11 (01)00630414056890(10)58311A67(17)20181211 97468A67 2018-Dec-11 (01)00630414056890(10)97468A67(17)20181211
Distribution pattern US Nationwide Distribution
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[22160]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 5
ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Z-0115-2019
Recall number Z-0115-2019
Initiated July 24, 2018
Classification Class II
Status Terminated
Quantity 379 sets
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
A potential bias was identified with certain kits compared to the internal standards.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0115-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3976]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall A potential bias was identified with certain kits compared to the internal standards.
Code information SMN 10309782 Lot # Expiry UDI # 35061 2019-02-10 (01)00630414056098(10)35061(17)20190210 39753 2020-06-11 (01)00630414056098(10)39753(17)20200611
Distribution pattern US Nationwide Distribution
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[28061]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 5
Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Z-0116-2019
Recall number Z-0116-2019
Initiated July 24, 2018
Classification Class II
Status Terminated
Quantity 97 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
A potential bias was identified with certain kits compared to the internal standards.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0116-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[26997]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall A potential bias was identified with certain kits compared to the internal standards.
Code information SMN 10995532 Lot # Expiry UDI # 57837A66 2018-12-11 (01)00630414598598(10)57837A66(17)20181211 67443A66 2018-12-11 (01)00630414598598(10)67443A66(17)20181211
Distribution pattern US Nationwide Distribution
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[28008]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 5
Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Z-0117-2019
Recall number Z-0117-2019
Initiated July 24, 2018
Classification Class II
Status Terminated
Quantity 2 sets
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
A potential bias was identified with certain kits compared to the internal standards.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0117-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50315]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall A potential bias was identified with certain kits compared to the internal standards.
Code information SMN 10995534 Lot # Expiry UDI # 11803 2019-02-10 (01)00630414598611(10)11803(17)20190210
Distribution pattern US Nationwide Distribution
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[27449]
FDA event record
· Exact recall-number query on openFDA
