Reported Apr 24, 2019 · Terminated
BIOPHEN LMWH Control C4, REF 224201
Aniara Diagnostica LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aniara Diagnostica LLC · 7768 Service Center Dr · West Chester, OH · 45069-2442
Is this the product you have?
BIOPHEN LMWH Control C4REF 224201
- Lot codes and dates
- Lots F1701555P4
- Amount recalled
- 3 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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