FDA Medical Device Recalls (openFDA)
Aniara Diagnostica LLC: BIOPHEN UFH Control Plasma
- Recall number
- Z-1743-2022
- Recalling firm
- Aniara Diagnostica LLC
- Product
- BIOPHEN UFH Control Plasma
- Status
- Terminated
- Initiated
- 2022-06-28
- Posted
- not on file
- Terminated
- 2024-04-18
- Reason
- Incorrect product labeling was included in the package.
- Root cause
- Under Investigation by firm
- Action
- A recall notification letter was issued on August 3, 2022 to impacted consignees. Consignees were informed that the product is packaged with the incorrect insert ("flyer"). The recalling firm instructs consignees to destroy the included incorrect insert and use the attached correct insert. An Awareness Acknowledgement Form should be completed and returned to the recalling firm acknowledging that the information was received and the incorrect inserts were destroyed.
- Quantity
- 13 units (1 unit is 1 box)
- Distribution
- Distribution in US - IL and MI
- Lot, serial or model codes
- UDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035
- 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