VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Reported: October 5, 2022 Initiated: February 9, 2022 #Z-0742-2022
Product Description
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Reason for Recall
Invalid calibrations (out of range high) while using the product.
Details
- Recalling Firm
- bioMerieux, Inc.
- Units Affected
- 480 kits
- Distribution
- Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution.
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.. Recalled by bioMerieux, Inc.. Units affected: 480 kits.
Why was this product recalled? ▼
Invalid calibrations (out of range high) while using the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2022. Severity: Moderate. Recall number: Z-0742-2022.
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