FDA Recall
Terminated
BIOPHEN LMWH Control C4, REF 224201
Recall: Z-1190-2019
·
Initiated March 19, 2019
Recall
- Recall Number
- Z-1190-2019
- Event Number
- 82468
- Firm
- Aniara Diagnostica LLC
- FEI Number
- 3005017664
- Product Code
- GGN
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- March 19, 2019
- Terminated
- July 12, 2019
- Address
- 7768 Service Center Dr, West Chester, OH, 45069-2442
Description
BIOPHEN LMWH Control C4, REF 224201
Reason
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Action
On March 18, 2019, the recalling firm notified its two affected customers of the recall via email. The email included an attached Urgent Medical Device Correction letter from HYPHEN BioMed, which informed customers that incorrect instructions for use had been packaged into specific lots of three device product codes. Customers were instructed to destroy the incorrect IFUs and begin using the corrected IFUs. Customers were also asked to complete and return customer response forms to Aniara Diagnostica.
Distribution
Distributed to accounts in MI and PA.
Quantity
3 units