Z-0422-2022Class II

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

Name: Z-0422-2022 RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD
Creator: Biomerieux Inc
Published: 2021-11-09
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2021-11-09 / Terminated / root cause: labeling and UDI

FDA source

Biomerieux Inc began a recall of RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD on 2021-11-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0422-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-09
Posted: 2021-12-27
Terminated: 2025-02-10
Recalling firm: bioMerieux, Inc.
Product: RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Product code: JSS Kit, Identification, Enterobacteriaceae
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 1,043 units
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.
Product codes and lots: Lot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0422-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0422-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-05	2021-12-27

Product code JSS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)