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Recall Observatory FDA recall evidence

Device product

VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.

Z-0742-2022

February 09, 2022

Class II

Product summary

Firm
bioMerieux, Inc.
Event
Event 89568
Status
Terminated
Classification
Class II
Quantity
480 kits
Official record key
device-enforcement:Z-0742-2022

Official wording

Reason: Invalid calibrations (out of range high) while using the product.

Code information: Lot numbers 1008873260, exp. 01JUN2022.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Invalid calibrations (out of range high) while using the product.