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PREMIER CAMPY

MERIDIAN BIOSCIENCE, INC. · Model 618096 · UDI-DI 00840733101717

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Premier CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures. Premier CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.

Recalls

Date	Firm	Reason
2002-07-15	Remel, Inc.	A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.

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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.