Z-1189-2019Class III

BIOPHEN UFH Control C1, REF 224101

Name: Z-1189-2019 BIOPHEN UFH Control C1, REF 224101
Creator: Aniara Diagnostica LLC
Published: 2019-03-19
License: https://open.fda.gov/license/

Aniara Diagnostica LLC / initiated 2019-03-19 / Terminated / root cause: labeling and UDI

FDA source

Aniara Diagnostica LLC began a recall of BIOPHEN UFH Control C1, REF 224101 on 2019-03-19. FDA classified it as Class III and gives the reason as "The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes". 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-1189-2019
Classification: Class III
Status: Terminated
Initiated: 2019-03-19
Posted: 2019-04-17
Terminated: 2019-07-12
Recalling firm: Aniara Diagnostica LLC
Product: BIOPHEN UFH Control C1, REF 224101
Product code: GGN Plasma, Coagulation Control
Reason for recall: The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Root cause tag: labeling and UDI
FDA 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 in commerce: 41 units
Distribution: Distributed to accounts in MI and PA.
Product codes and lots: Lots F1700314P2, F1700314P3, F1700314P4, F1801638P1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1189-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1188-2019	Class III	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17
Z-1189-2019	Class III	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17
Z-1190-2019	Class III	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17

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)