Z-1743-2022Class III

BIOPHEN UFH Control Plasma

Name: Z-1743-2022 BIOPHEN UFH Control Plasma
Creator: Aniara Diagnostica LLC
Published: 2022-06-28
License: https://open.fda.gov/license/

Aniara Diagnostica LLC / initiated 2022-06-28 / Terminated / root cause: labeling and UDI

FDA source

Aniara Diagnostica LLC began a recall of BIOPHEN UFH Control Plasma on 2022-06-28. FDA classified it as Class III and gives the reason as "Incorrect product labeling was included in the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1743-2022
Classification: Class III
Status: Terminated
Initiated: 2022-06-28
Posted: 2022-09-15
Terminated: 2024-04-18
Recalling firm: Aniara Diagnostica LLC
Product: BIOPHEN UFH Control Plasma
Product code: GGN Plasma, Coagulation Control
Reason for recall: Incorrect product labeling was included in the package.
Root cause tag: labeling and UDI
FDA 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 in commerce: 13 units (1 unit is 1 box)
Distribution: Distribution in US - IL and MI
Product codes and lots: UDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1743-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1743-2022	Class III	Terminated	Voluntary: Firm initiated	2022-09-21	2022-09-15

Product code GGN

K051472Class IIBiophen Lmwh Control, Lmwh Control Low, Ufh Control, Heparin Calibrator & Ufh CalibratorHyphen Biomed / cleared 2005-12-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)