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ACCUPROBE®

Hologic, Inc. · Model KIT DETECTION RGT (CE) · UDI-DI 15420045506459

LQF Prescription
10
510(k) clearances
2
Adverse events
2
Recalls
0
Facilities

Description

Detection Reagent Kit.

Recalls

DateFirmReason
2008-12-30Gen-Probe IncThis recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with corr
2008-12-30Gen-Probe IncThis recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with corr

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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.