Lower riskMedical device recall · FDA · Published January 25, 2022
Medline ImmunoCard Rotavirus Test Recall: Incorrect Shipping Temperature
Medline Industries recalls Meridian Bioscience Immunocard STAT! Rotavirus tests due to being shipped at room temperature instead of refrigerated. This could lead to inaccurate test results.
“Medline ImmunoCard Rotavirus Test Recall: Incorrect Shipping Temperature.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61223-medline-immunocard-rotavirus-test-recall-incorrect-shipping-temperature. Based on FDA recall #Z-0678-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0678-2022%22&limit=1).
The FDA announced on Jan. 25, 2022, that Medline Industries LP recalled Meridian Bioscience ImmunoCard STAT! Rotavirus tests because they were incorrectly shipped at room temperature instead of being refrigerated. The agency classified the recall as Class II.
According to the FDA, the product was incorrectly shipped at room temperature rather than refrigerated. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool.
Context
GovInfoNow's records show Medline Industries LP has had 119 other recalls on record since Oct. 22, 2021. Other recent recalls of similar products include Medline Convenience Kits: Temperature Probe Recall Due to Distribution Error (May 28, 2026) and Covidien Mon-a-Therm Temperature Probe Recall: Lack of FDA Clearance (April 23, 2026).
How to tell if you have this one
Check the lot number on the test kit box. The affected lots are 750030M481 (expires 4/29/2022), 750030N482 (expires 12/2/2022), and 750030N483 (expires 5/17/2023).
Brand
Medline Industries
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for the lot number on the test kit box to determine if it's affected.
Where it went and when
Where it was distributed
Distributed in 7 states.
Listed by the agency
Not listed
FDA distribution: “US Distribution was made to IL, FL, LA, MS, NC, OH, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Illinois, Louisiana, Mississippi, North Carolina, Ohio, Texas.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0678-2022 (January 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0678-2022 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.