Lower risk Medical device recall · FDA · Published November 9, 2021

Biomerieux RAPID 20 E System Recall: Incorrect Negative Result Color in Package Insert

Biomerieux recalls RAPID 20 E system (lot 1008332150, exp 2022-04-20; lot 1008787180, exp 2022-12-12) due to incorrect color for negative CIT test results in package insert.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0422-2022Medical device Biomerieux ›

Lower-risk 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.

Take action

Contact the company

Recalling firmBiomerieux Inc595 Anglum Rd · Hazelwood, MO 63042-2320

✎ GovInfoNow plain-language explainer

Biomerieux is recalling its RAPID 20 E system because the package insert shows the wrong color for a negative result in the CIT test. This could lead to misinterpreting test results, but it does not pose a physical safety risk. Read more at govinfonow.com/recall/61558-biomerieux-rapid-20-e-system-recall-incorrect-negative-result-color.

Source Summary by GovInfoNow · govinfonow.com/recall/61558-biomerieux-rapid-20-e-system-recall-incorrect-negative-result-color · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0422-2022

Cite this page

“Biomerieux RAPID 20 E System Recall: Incorrect Negative Result Color in Package Insert.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61558-biomerieux-rapid-20-e-system-recall-incorrect-negative-result-color. Based on FDA recall #Z-0422-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0422-2022%22&limit=1).

The FDA announced on 2021-11-09 that Biomerieux Inc is recalling the RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours due to an error in the package insert. The hazard involves an incorrect color listed for a negative CIT test result.

How to tell if you have it

Brand: Biomerieux
Product: RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD
Lot numbers: 1008332150 (Exp. 20-APR-2022), 1008787180 (Exp. 12-DEC-2022)
Units affected: 1,043

The hazard

According to the FDA, there is an error in the new version of the package insert for the recalled device. The Reading Table lists the incorrect color for a negative result for the CIT test.

Context

GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since 2017-07-12. Recent Biomerieux recalls include the VITEK 2 AST-N461 Test Kit Recall (2026-07-24), the VITEK 2 AST-N447 Kit Recall (2026-06-04), and a recall regarding VITEK 2 Gram-negative Susceptibility Cards (2026-01-05). Other recent recalls of similar products include Changchun Wancheng Bio-Electron UTI Test Strips Recall (2025-11-22), BioFire Respiratory Panel 2.1 Recall (2025-10-22), and Menopause Test Cassette Recall (2025-11-22).

How to tell if you have this one

Check for lot numbers 1008332150 (expires April 20, 2022) or 1008787180 (expires December 12, 2022) on the RAPID 20 E system packaging.

Brand
Biomerieux
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Package Insert
Verify the color code for negative results in the package insert matches the correct color as specified by Biomerieux.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 31 states.

FDA 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 read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Massachusetts, Michigan, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 3.3 years after the firm started it.

Nov 9, 2021Firm started the recall
Dec 27, 2021FDA classified it Class II
Jan 5, 2022Published in FDA’s Enforcement Report
Feb 10, 2025FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61558-biomerieux-rapid-20-e-system-recall-incorrect-negative-result-color">Biomerieux RAPID 20 E System Recall: Incorrect Negative Result Color in Package Insert (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0422-2022 (November 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0422-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.