FDA Medical Device Recalls (openFDA)
Biomerieux Inc: RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
- Recall number
- Z-0422-2022
- Recalling firm
- Biomerieux Inc
- Product
- RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
- Status
- Terminated
- Initiated
- 2021-11-09
- Posted
- not on file
- Terminated
- 2025-02-10
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Lot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSS
- Firm FEI
- 1950204
- Firm city
- Hazelwood
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28