17 results
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47ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Yeastone Broth, 11ML, 10/BOX YY3462
FDA Enforcement
Class II
·Ongoing·Remel, Inc·April 22, 2026
Campy CVA Medium 100/PK, R01272
FDA Enforcement
Class II
·Ongoing·Remel, Inc·March 4, 2026
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
FDA Enforcement
Class II
·Ongoing·Remel, Inc·December 3, 2025
Strep Selective II Agar, Product Number R01859
FDA Enforcement
Class II
·Ongoing·Remel, Inc·August 6, 2025
Blood/MacConkey Biplate 100/PK, Product Number R02049
FDA Enforcement
Class II
·Ongoing·Remel, Inc·August 6, 2025
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
FDA Enforcement
Class II
·Ongoing·Remel, Inc·August 6, 2025
Blood/EMB, Levine 100/PK, Product Number R02041
FDA Enforcement
Class II
·Ongoing·Remel, Inc·August 6, 2025
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
FDA Enforcement
Class II
·Ongoing·Remel, Inc·February 26, 2025
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
FDA Enforcement
Class II
·Ongoing·Remel, Inc·February 26, 2025
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
FDA Enforcement
Class II
·Ongoing·Remel, Inc·November 6, 2024
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
FDA Enforcement
Class II
·Ongoing·Remel, Inc·September 20, 2023
Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
FDA Enforcement
Class II
·Ongoing·Remel Inc·April 21, 2021
Remel 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.
FDA Enforcement
Class II
·Ongoing·Remel, Inc·July 5, 2023
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
FDA Enforcement
Class II
·Ongoing·Remel Inc·March 16, 2022
Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
FDA Enforcement
Class II
·Ongoing·Remel Inc·April 21, 2021
Zebra 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
FDA Enforcement
Class II
·Ongoing·Remel, Inc·March 26, 2025
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
FDA Enforcement
Class II
·Ongoing·Remel, Inc·June 18, 2025