Remel CM040: Incorrect Cation Label May Affect Lab Test Accuracy
Remel recalls Mueller-Hinton Broth IVD (500g) due to potential incorrect cation labeling, which could lead to inaccurate lab test results. Affected lots: 1865331, expiring 06/2021.
Lower-risk recall
Product may have incorrect cation information detailed on the product label.
Contact the company
What happened, in plain English
Remel is recalling Mueller-Hinton Broth IVD (500g) because the product label might have incorrect cation information. This could cause lab tests to give inaccurate results if used without correction. Read more at govinfonow.com/recall/72636-remel-cm040-incorrect-cation-label-may-affect-lab-test-accuracy.
Source Summary by GovInfoNow · govinfonow.com/recall/72636-remel-cm040-incorrect-cation-label-may-affect-lab-test-accuracy · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0209-2018
Cite this page
“Remel CM040: Incorrect Cation Label May Affect Lab Test Accuracy.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72636-remel-cm040-incorrect-cation-label-may-affect-lab-test-accuracy. Based on FDA recall #Z-0209-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0209-2018%22&limit=1).
Why it’s dangerous
The product label might show incorrect cation information, which is critical for accurate bacterial culture testing. If the cations are wrong, lab results could be inaccurate, potentially leading to incorrect diagnoses or treatments.
Who’s affected
Lab technicians and healthcare facilities using this specific broth for bacterial culture testing. Those who have the lot number 1865331 (expiring June 2021) are most at risk.
How to tell if you have this one
Check for the lot number 1865331 on the label. The product is a 500g Mueller-Hinton Broth IVD that makes 23.8 liters of culture medium, expiring June 2021.
- Brand
Remel- Category
Medical device
What to do — step by step
Check Label for Cation Information
Verify the cation details on the product label to ensure they match the correct specifications for accurate lab testing.
Where it went and when
Where it was distributed
Distributed in 5 states.
FDA distribution: “Distribution was made to AL, MD, ME, NC, and TN. There was no foreign/military/government distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Maine, Maryland, North Carolina, Tennessee.
Recall timeline
FDA terminated this recall 2.8 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-0209-2018 (November 2, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0209-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 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.