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Device, Specimen Collection
FDA product code LIO · Class 1 · Microbiology
182
Registered devices
180
Adverse events
3
Recalls
63
510(k) clearances
Devices with this code
Puritan — Puritan Medical ProductsSigma Virocult — MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDAmies Clear Gel,Single Swab PK/500 — REMEL, INC.BD BBL Polyester Fiber-Tipped Applicator Swab — BECTON, DICKINSON AND COMPANYPuritan — Puritan Medical ProductsREMEL — REMEL, INC.Transwab — MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDPuritan UniTranz-RT — Puritan Medical ProductsStarswab II Bacteriology Culture Collection and Transport System — Pretium Canada Packaging ULCCARDINAL HEALTH — Cardinal Health 200, LLCCaplugs/Evergreen — CAPlugsSigma Virocult — MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDBD Affirm™ VPIII Ambient Temperature Transport System — BECTON, DICKINSON AND COMPANYTranswab — MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDPuritan UniTranz-RT — Puritan Medical ProductsUTM® — COPAN ITALIA SPASigma Virocult — MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDRealTime — ABBOTT MOLECULAR INC.Transwab — MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDTranswab — MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDCARDINAL HEALTH — Cardinal Health 200, LLCTranswab — MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDREMEL — REMEL, INC.VACUETTE — Greiner Bio-One GmbH
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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