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

Recalled January 5, 2022 · FDA recall Z-0422-2022 · Biomerieux

Hazard

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. · FDA Class II

Units

1,043 units

Sold at

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.

Description

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.

Product

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

Manufacturer(s)

Biomerieux Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →