Remel Sensititre Gram Negative Testing Plates: Low MICs Risk
Remel recalls Sensititre Gram Negative Susceptibility Testing Plates with potential lower than expected MICs for some gram-negative bacteria. Affected lots have specific expiration dates.
Lower-risk recall
There are lower than expected MICs for some gram negative species.
Contact the company
What happened, in plain English
Remel is recalling Sensititre Gram Negative Susceptibility Testing Plates due to possible lower than expected minimum inhibitory concentrations (MICs) for some gram-negative bacteria. This could lead to inaccurate antibiotic susceptibility testing results, which might affect treatment decisions. Read more at govinfonow.com/recall/61286-remel-sensititre-gram-negative-testing-plates-low-mics-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/61286-remel-sensititre-gram-negative-testing-plates-low-mics-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0722-2022
Cite this page
“Remel Sensititre Gram Negative Testing Plates: Low MICs Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/61286-remel-sensititre-gram-negative-testing-plates-low-mics-risk. Based on FDA recall #Z-0722-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0722-2022%22&limit=1).
Why it’s dangerous
The plates may show lower than expected minimum inhibitory concentrations (MICs) for certain gram-negative bacteria. This could cause inaccurate antibiotic susceptibility test results, potentially leading to incorrect treatment decisions if the testing is used for clinical purposes.
Who’s affected
Laboratories using these testing plates for antibiotic susceptibility testing are affected. Researchers and clinical staff who rely on these plates for accurate bacterial resistance testing are most at risk.
How to tell if you have this one
Check for the product number MDRGN2F on the plate. Affected lots include B1402A (expires Oct 2022), B1315A (expires Aug 2022), B1211 (expires May 2022), B1161A (expires Apr 2022), B0361 (expires Aug 2021), and B0164B (expires Apr 2021).
- Brand
Remel- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for the lot numbers B1402A, B1315A, B1211, B1161A, B0361, or B0164B on the plate.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distribution throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0722-2022 (January 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0722-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.