FDAFDA · Food and drugs·Recall number Z-0432-2022
VIDAS RUB IgG (RBG), REF 30226
Published January 5, 2022 · Recall initiated: September 22, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- bioMerieux, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- UDI 03573026138585, Lot #: 1008694980, 1008700260, 1008828980
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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