VIDAS Lyme IgG II (LYM), REF 417401
Reported: January 5, 2022 Initiated: September 22, 2021 #Z-0437-2022
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.
Details
- Recalling Firm
- bioMerieux, Inc.
- Units Affected
- Two lots
- Distribution
- US Nationwide distribution.
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
VIDAS Lyme IgG II (LYM), REF 417401. Recalled by bioMerieux, Inc.. Units affected: Two lots.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 5, 2022. Severity: Moderate. Recall number: Z-0437-2022.
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