PlainRecalls
FDA Devices Moderate Class II Ongoing

VIDAS RUB IgG (RBG), REF 30226

Reported: January 5, 2022 Initiated: September 22, 2021 #Z-0432-2022

Product Description

VIDAS RUB IgG (RBG), REF 30226

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
Three lots
Distribution
US Nationwide distribution.
Location
Durham, NC

Frequently Asked Questions

What product was recalled?
VIDAS RUB IgG (RBG), REF 30226. Recalled by bioMerieux, Inc.. Units affected: Three 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-0432-2022.