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REMEL
REMEL, INC. · Model R21765 · UDI-DI 00848838024252
1
510(k) clearances
175
Adverse events
3
Recalls
43
Facilities
Description
Zinc PVA Fixative (15ml Vial) PK/12
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 overfilled with extract |
| 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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