—#190365

Product

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

FDA product code: JSS — Kit, Identification, Enterobacteriaceae
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Lot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

bioMerieux in the U.S. issued an Urgent Field Safety Notice dated November 2021 on 11/9/2021 via email for delivery to the Lab Director or Lab Manager. The notice described the issue, impact to the customer, and listed the required customer actions: Distribute the information to all appropriate personnel in their laboratory and forward the information to all parties that may use the product, including others to whom the product may have been transferred. The customer is informed they can continue to use RAPID 20 E, however, they must refer to the following Reading Table or to the corrected RAPID 20 E package insert version "G1" available on Resource Center when reading the CIT test result. For tests previously performed using RAPID 20 E, the customer is strongly recommended that they identify any possible misidentifications to analyze the related risks and to determine appropriate actions, if relevant. An Acknowledgement Form was enclosed to confirm receipt of the notice.

Recalling firm

Firm: Biomerieux Inc
Address: 595 Anglum Rd, Hazelwood, Missouri 63042-2320

Distribution

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.

Timeline

Recall initiated: 2021-11-09
Terminated: 2025-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190365. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.