Recall archive / FDA device enforcement
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD. — FDA record Z-0422-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 9, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
- 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.
- Classification
- Class II
- Recalling firm
- Biomerieux Inc
- Quantity
- 1,043 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0422-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 5, 2022
- Recall initiation date
- Nov 9, 2021
- Center classification date
- Dec 27, 2021
- Termination date
- Feb 10, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.