BIOPHEN UFH Control C1, REF 224101
- Company
- Aniara Diagnostica Llc
- Recall Initiated
- March 19, 2019
- Terminated
- July 12, 2019
- Recall Number
- Z-1189-2019
- Quantity
- 41 units
- Firm Location
- West Chester, OH
Reason for Recall
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Distribution
Distributed to accounts in MI and PA.
Lot / Code Info
Lots F1700314P2, F1700314P3, F1700314P4, F1801638P1
Root Cause
Error in labeling
Action Taken
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.
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