Recall Z-1188-2019— Aniara Diagnostica LLC

Name: FDA recall Z-1188-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-19

Class III · Terminated

Class III FDA medical device recall by Aniara Diagnostica LLC, initiated 2019-03-19, terminated 2019-07-12. It names one FDA 510(k) clearance: K051472. Product: BIOPHEN UFH Control C2, REF 223901. Reason: The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes..

Recalling firm: Aniara Diagnostica LLC
Classification: Class III
Status: Terminated
Initiated: 2019-03-19
Terminated: 2019-07-12
Firm location: West Chester, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K051472 — BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATORHyphen Biomed·cleared 2005-12-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BIOPHEN UFH Control C2, REF 223901

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.