Recall Z-0437-2022— bioMerieux, Inc.
Class II · Ongoing
Class II FDA medical device recall by bioMerieux, Inc., initiated 2021-09-22. FDA's recall record names no specific 510(k) clearance for this event. Product: VIDAS Lyme IgG II (LYM), REF 417401. 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
Product description
VIDAS Lyme IgG II (LYM), REF 417401
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.