VIDAS SARS-COV-2 IgM, Ref 423833-01
Reported: January 5, 2022 Initiated: September 22, 2021 #Z-0438-2022
Product Description
VIDAS SARS-COV-2 IgM, Ref 423833-01
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.
Details
- Recalling Firm
- bioMerieux, Inc.
- Units Affected
- One lot
- Distribution
- US Nationwide distribution.
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
VIDAS SARS-COV-2 IgM, Ref 423833-01. Recalled by bioMerieux, Inc.. Units affected: One lot.
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-0438-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11