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Device, Specimen Collection
FDA product code LIO · Class 1 · Microbiology
165
Registered devices
175
Adverse events
3
Recalls
63
510(k) clearances
Devices with this code
Xpert Vaginal/Endocervical Specimen Collection Kit — CEPHEIDPuritan Opti-Swab — Puritan Medical ProductsCARDINAL HEALTH — Cardinal Health 200, LLCPuritan UniTranz-RT — Puritan Medical ProductsSigma Virocult — MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDSigma Virocult — MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDREMEL — REMEL, INC.Amies Clear Gel,Dual Swab PK/50 — REMEL, INC.Sigma Transwab — MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDPuritan UniTranz-RT — Puritan Medical ProductsOEM CUSTOMER SPECIFIC — Cardinal Health 200, LLCVACUETTE — Greiner Bio-One GmbHSigma Transwab — MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDCopan Universal Transport Medium (UTM-RT) System — COPAN ITALIA SPAPuritan UniTranz-RT — Puritan Medical ProductsSigma Virocult — MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDCovidien — Cardinal Health 200, LLCcobas® PCR Media Uni Swab Sample Kit — Roche Molecular Systems, Inc.Copan Universal Transport Medium (UTM-RT) System — COPAN ITALIA SPACARDINAL HEALTH — Cardinal Health 200, LLCRealTime — ABBOTT MOLECULAR INC.Transwab — MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDVACUETTE — Greiner Bio-One GmbHPuritan — Puritan Medical Products
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-08 | Hologic, 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 ove |
| 2020-07-14 | Thomas Scientific | The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval. |
| 2009-05-07 | Remel, Inc | Incorrect expiration date on the product |
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