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Remel, Inc FDA Recalls
29 recalls on file across devices, 9 of them Class I and 17 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460Class IIJun 3, 2026Reduced or no recovery of some strains of Neisseria gonorrho |
| Yeastone Broth, 11ML, 10/BOX YY3462Class IIMar 24, 2026Products may report incorrect AST results during quality con |
| Campy CVA Medium 100/PK, R01272Class IIFeb 5, 2026Customer complaints report low to no recovery of Campylobact |
| 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450Class IINov 12, 2025Products may contain contamination, which may result in a da |
| Strep Selective II Agar, Product Number R01859Class IIJul 11, 2025The products may contain surface and subsurface contaminatio |
| Blood Agar,5% Sheep Blood 100/PK, Product Number R01202Class IIJul 11, 2025The products may contain surface and subsurface contaminatio |
| Blood/MacConkey Biplate 100/PK, Product Number R02049Class IIJul 11, 2025The products may contain surface and subsurface contaminatio |
| Blood/EMB, Levine 100/PK, Product Number R02041Class IIJul 11, 2025The products may contain surface and subsurface contaminatio |
| Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invClass IIMay 1, 2025Product may have an off color affecting perfomance |
| remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic useClass IIFeb 13, 2025Product may contain surface and subsurface contamination of |
| remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic useClass IIFeb 13, 2025Product may contain surface and subsurface contamination of |
| Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for SeClass IIFeb 12, 2025Power supply unit for Zebra Printers used with the device ca |
| remel BactiDrop Acridine Orange, REF 21502, 50 per package.Class IISep 20, 2024A color change of the solution within the dropper can occur |
| remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containiClass IIAug 14, 2023On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recov |
| Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk,Class IIMay 31, 2023The test medium may not perform as intended. |
| Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD ASTClass IOct 20, 2022An internal technical investigation has confirmed that Therm |
| Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD ASTClass IOct 20, 2022An internal technical investigation has confirmed that Therm |
| Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD ASTClass IOct 20, 2022An internal technical investigation has confirmed that Therm |
| Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD ASTClass IOct 20, 2022An internal technical investigation has confirmed that Therm |
| Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD ASTClass IOct 20, 2022An internal technical investigation has confirmed that Therm |
| Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD ASTClass IOct 20, 2022An internal technical investigation has confirmed that Therm |
| Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD ASTClass IOct 20, 2022An internal technical investigation has confirmed that Therm |
| Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD ASTClass IOct 20, 2022An internal technical investigation has confirmed that Therm |
| Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD ASTClass IOct 20, 2022An internal technical investigation has confirmed that Therm |
| Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD formatClass IIJan 10, 2022There are lower than expected MICs for some gram negative sp |
| ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United KingdomClass IIJun 18, 2021Out of Specification |
| Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative prClass IIApr 22, 2021The media allows growth of E. faecalis ATCC 29212 with black |
| Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommeClass IIMar 10, 2021When tested with H. influenza ATCC 49247 and ATCC 49766 both |
| Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommClass IIMar 10, 2021When tested with H. influenza ATCC 49247 and ATCC 49766 both |