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bioMerieux, Inc. Recall 89568

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

bioMerieux, Inc. Recall 89568 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0742-2022
Event ID89568
Event DescriptionVIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Product TypeDevices
DistributionDistribution 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.
Quantity480 kits
Recall ReasonInvalid calibrations (out of range high) while using the product.
Device Classification20221005
Device Code InfoLot numbers 1008873260, exp. 01JUN2022.
Center Classification Date20220314
Recall Initiation Date20220209
Recalling FirmbioMerieux, Inc.
Initial Notification Letter
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