PlainRecalls
FDA Devices Moderate Class II Ongoing

VIDAS PRG Progesterone, REF 30409-01

Reported: January 5, 2022 Initiated: September 22, 2021 #Z-0424-2022

Product Description

VIDAS PRG Progesterone, REF 30409-01

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
1818 units
Distribution
US Nationwide distribution.
Location
Durham, NC

Frequently Asked Questions

What product was recalled?
VIDAS PRG Progesterone, REF 30409-01. Recalled by bioMerieux, Inc.. Units affected: 1818 units.
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-0424-2022.