FDA Medical Device Recalls (openFDA)
Aniara Diagnostica LLC: BIOPHEN UFH Control C1, REF 224101
- Recall number
- Z-1189-2019
- Recalling firm
- Aniara Diagnostica LLC
- Product
- BIOPHEN UFH Control C1, REF 224101
- Status
- Terminated
- Initiated
- 2019-03-19
- Posted
- not on file
- Terminated
- 2019-07-12
- Reason
- The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
- Root cause
- Error in labeling
- 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.
- Quantity
- 41 units
- Distribution
- Distributed to accounts in MI and PA.
- Lot, serial or model codes
- Lots F1700314P2, F1700314P3, F1700314P4, F1801638P1
- 510(k) numbers
- ["K051472"]
- PMA numbers
- not on file
- Product code
- GGN
- Firm FEI
- 3005017664
- Firm city
- West Chester
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28