BIOPHEN UFH Control Plasma recallZ-1743-2022 · Aniara Diagnostica LLC · initiated Jun 28, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aniara Diagnostica LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect product labeling was included in the package.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1743-2022
- Status
- Terminated
- Initiated by the company
- Jun 28, 2022
- Recalling firm
- Aniara Diagnostica LLC
- Quantity
- 13 units (1 unit is 1 box)
- Product code
- GGN
- FDA submissions
- K051472
- Distribution
- Distribution in US - IL and MI
Product description
BIOPHEN UFH Control Plasma
Code information (models, lots, serial numbers)
UDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BIOPHEN UFH Control Plasma 223101Hyphen Biomed · Plasma, Coagulation Control1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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