Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

BIOPHEN UFH Control C1, REF 224101

FDA Recall Z-1189-2019 · Posted None

Recalling FirmAniara Diagnostica LLC
Recall StatusTerminated
Product CodeGGN
Date Initiated2019-03-19
Date Terminated2019-07-12
Product Quantity41 units

Reason for Recall

The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

Distributed to accounts in MI and PA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051472BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATORHyphen Biomed · 2005-12-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑