BIOPHEN UFH Control C2, REF 223901
Reported: April 24, 2019 Initiated: March 19, 2019 #Z-1188-2019
Product Description
BIOPHEN UFH Control C2, REF 223901
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
- 14 kits
- Distribution
- Distributed to accounts in MI and PA.
- Location
- West Chester, OH
Frequently Asked Questions
What product was recalled? ▼
BIOPHEN UFH Control C2, REF 223901. Recalled by Aniara Diagnostica LLC. Units affected: 14 kits.
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-1188-2019.
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