Recall Z-1244-2022— Helena Laboratories, Corp.

Name: FDA recall Z-1244-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-06

Class II · Ongoing

Class II FDA medical device recall by Helena Laboratories, Corp., initiated 2022-04-06. It names one FDA 510(k) clearance: K111369. Product: V8 Immunodisplacement Kit REF 1803. Reason: Due to microbial growth causing interference with interpretation..

Recalling firm: Helena Laboratories, Corp.
Classification: Class II
Status: Ongoing
Initiated: 2022-04-06
Firm location: Beaumont, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K111369 — THE HELENA V8 IMMUNODISPLACEMENT KITHelena Laboratories Uk, Ltd.·cleared 2012-06-26

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

V8 Immunodisplacement Kit REF 1803

Reason for recall

Due to microbial growth causing interference with interpretation.

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