ImmunoCard STAT Rotavirus diagnostic tests recalled for improper storage temperature
Meridian BioscienceImmunoCard STAT! Rotavirus tests were shipped at room temperature instead of refrigerated, which may affect their reliability.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II precautionary recall involving improper storage handling of a diagnostic device. No illnesses, injuries, or test failures have been reported. The hazard is a storage and handling issue rather than a product manufacturing defect.
Plain-English summary
The Meridian BioscienceImmunoCard STAT! Rotavirus test (model REF 750030) has been recalled because the product was shipped at room temperature instead of refrigerated as required.
The recalled kit contains 30 tests per box. Nineteen kits were affected and shipped to Illinois, Florida, Louisiana, Mississippi, North Carolina, Ohio, and Texas. The affected lot numbers are 750030M481 (expiration 4/29/2022), 750030N482 (expiration 12/2/2022), and 750030N483 (expiration 5/17/2023).
Improper temperature exposure during shipping may affect the test's reliability in detecting rotavirus antigen. Users who received affected products should verify their lot numbers and contact Medline Industries with any concerns.
The recalled product
- Product
- meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotaviru
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot numbers 750030M481
- Exp. 4/29/2022
- 750030N482
- Exp. 12/2/2022
- and 750030N483
- Exp. 5/17/2023.
Distribution
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