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PREMIER Rotaclone

MERIDIAN BIOSCIENCE, INC. · Model 696004 · UDI-DI 00840733101700

LIQ Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
13
Facilities

Description

Premier Rotaclone is an Enzyme Immunoassay (EIA) intended for the detection of rotavirus antigen in human fecal specimens.

Recalls

DateFirmReason
2022-01-25MEDLINE INDUSTRIES, LP - NorthfieldThe product was incorrectly shipped at room temperature rather than refrigerated.
2021-12-01MEDLINE INDUSTRIES, LP - NorthfieldProduct stored incorrectly in temperature controlled setting instead of refrigeration.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.