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Recall Observatory FDA recall evidence

Device product

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

Z-0422-2022

November 09, 2021

Class II

Product summary

Firm
Biomerieux Inc
Event
Event 89041
Status
Terminated
Classification
Class II
Quantity
1,043 units
Official record key
device-enforcement:Z-0422-2022

Official wording

Reason: There 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.

Code information: Lot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022

Distribution pattern: US 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There 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.