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Biomerieux Inc Recall 89041

Description: RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.

Biomerieux Inc Recall 89041 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0422-2022
Event ID89041
Event DescriptionRAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Product TypeDevices
DistributionUS Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, and WI. There was government distribution but no military distribution.
Quantity1,043 units
Recall ReasonThere is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
Device Classification20220105
Device Code InfoLot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022
Center Classification Date20211227
Recall Initiation Date20211109
Recalling FirmBiomerieux Inc
Initial Notification Letter
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