Remel, Inc
11 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Remel, Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-08-06FDA-DeviceClass IIBlood/MacConkey Biplate 100/PK, Product Number R02049
The products may contain surface and subsurface contamination of Listeria monocytogenes.
- 2025-08-06FDA-DeviceClass IIBlood/EMB, Levine 100/PK, Product Number R02041
The products may contain surface and subsurface contamination of Listeria monocytogenes.
- 2025-08-06FDA-DeviceClass IIStrep Selective II Agar, Product Number R01859
The products may contain surface and subsurface contamination of Listeria monocytogenes.
- 2025-08-06FDA-DeviceClass IIBlood Agar,5% Sheep Blood 100/PK, Product Number R01202
The products may contain surface and subsurface contamination of Listeria monocytogenes.
- 2025-06-18FDA-DeviceClass IIThermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Product may have an off color affecting perfomance
- 2025-03-26FDA-DeviceClass IIZebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ
Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
- 2025-02-26FDA-DeviceClass IIremel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
- 2025-02-26FDA-DeviceClass IIremel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
- 2024-11-06FDA-DeviceClass IIremel BactiDrop Acridine Orange, REF 21502, 50 per package.
A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.
- 2023-09-20FDA-DeviceClass IIremel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples
- 2023-07-05FDA-DeviceClass IIRemel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.
The test medium may not perform as intended.
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