FDA recall Z-0422-2022

Product

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

Reason for recall

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2021-11-09

Report date

2022-01-05

Termination date

2025-02-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hazelwood, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0422-2022