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Sigma Virocult

MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED · Model N/a · UDI-DI 05060259070525

LIO
1
510(k) clearances
175
Adverse events
3
Recalls
43
Facilities

Description

Sigma Virocult Sigma ENT breakpoint + 2ml VTM large vial

Recalls

DateFirmReason
2025-01-08Hologic, Inc.Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extract
2020-07-14Thomas ScientificThe firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.
2009-05-07Remel, IncIncorrect expiration date on the product

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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.