FDA-Device2022-01-05Class II
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Biomerieux Inc
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.
Sold states
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.
Affected count
1,043 units
Manufactured in
595 Anglum Rd, Hazelwood, MO, United States
Products
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0422-2022Don't want to check this manually?
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