Recall Z-0427-2022— bioMerieux, Inc.

Name: FDA recall Z-0427-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-22

Class II · Ongoing

Class II FDA medical device recall by bioMerieux, Inc., initiated 2021-09-22. It names one FDA 510(k) clearance: K141133. Product: VIDAS DEX@, Dimer Exclusion II, REF 30455-01. Reason: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test..

Recalling firm: bioMerieux, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-09-22
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K141133 — VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion IIBIOMERIEUX·cleared 2015-07-09

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

VIDAS DEX@, Dimer Exclusion II, REF 30455-01

Reason for recall

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

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