BIOPHEN LMWH Control C4, REF 224201
Reported: April 24, 2019 Initiated: March 19, 2019 #Z-1190-2019
Product Description
BIOPHEN LMWH Control C4, REF 224201
Reason for Recall
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Details
- Recalling Firm
- Aniara Diagnostica LLC
- Units Affected
- 3 units
- Distribution
- Distributed to accounts in MI and PA.
- Location
- West Chester, OH
Frequently Asked Questions
What product was recalled? ▼
BIOPHEN LMWH Control C4, REF 224201. Recalled by Aniara Diagnostica LLC. Units affected: 3 units.
Why was this product recalled? ▼
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2019. Severity: Low. Recall number: Z-1190-2019.
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