Recall events
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Event 82468
Event summary
Timeline bucket March 19, 2019
Product types Device
Classifications Class III
Statuses Terminated
Recalling firm wording Aniara Diagnostica LLC
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
3 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 3
BIOPHEN UFH Control C2, REF 223901
Z-1188-2019
Recall number Z-1188-2019
Initiated March 19, 2019
Classification Class III
Status Terminated
Quantity 14 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Error in labeling
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1188-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15136]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Code information Lot F1700315P7
Distribution pattern Distributed to accounts in MI and PA.
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[28692]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 3
BIOPHEN UFH Control C1, REF 224101
Z-1189-2019
Recall number Z-1189-2019
Initiated March 19, 2019
Classification Class III
Status Terminated
Quantity 41 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Error in labeling
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1189-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38984]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Code information Lots F1700314P2, F1700314P3, F1700314P4, F1801638P1
Distribution pattern Distributed to accounts in MI and PA.
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[28549]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 3
BIOPHEN LMWH Control C4, REF 224201
Z-1190-2019
Recall number Z-1190-2019
Initiated March 19, 2019
Classification Class III
Status Terminated
Quantity 3 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Error in labeling
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1190-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11172]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Code information Lots F1701555P4
Distribution pattern Distributed to accounts in MI and PA.
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[28301]
FDA event record
· Exact recall-number query on openFDA
