Remel Inc

FDA Regulatory Profile

Summary

Total Recalls
84 (9 Class I)
510(k) Clearances
154
Inspections
11
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1474-2026Class IICampy CVA Medium 100/PK, R01272February 5, 2026
Z-0585-2026Class II1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450November 12, 2025
Z-2224-2025Class IIStrep Selective II Agar, Product Number R01859July 11, 2025
Z-2223-2025Class IIBlood Agar,5% Sheep Blood 100/PK, Product Number R01202July 11, 2025
Z-2225-2025Class IIBlood/EMB, Levine 100/PK, Product Number R02041July 11, 2025
Z-2226-2025Class IIBlood/MacConkey Biplate 100/PK, Product Number R02049July 11, 2025
Z-1947-2025Class IIThermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse BloMay 1, 2025
Z-1201-2025Class IIremel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic useFebruary 13, 2025
Z-1200-2025Class IIremel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic useFebruary 13, 2025
Z-1395-2025Class IIZebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optioFebruary 12, 2025
Z-0266-2025Class IIremel BactiDrop Acridine Orange, REF 21502, 50 per package.September 20, 2024
Z-2531-2023Class IIremel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinicaAugust 14, 2023
Z-2038-2023Class IIRemel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (May 31, 2023
Z-0332-2023Class IThermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD ASTOctober 20, 2022
Z-0331-2023Class IThermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD ASTOctober 20, 2022
Z-0330-2023Class IThermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD ASTOctober 20, 2022
Z-0327-2023Class IThermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD ASTOctober 20, 2022
Z-0328-2023Class IThermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD ASTOctober 20, 2022
Z-0333-2023Class IThermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD ASTOctober 20, 2022
Z-0335-2023Class IThermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD ASTOctober 20, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K162620Remel Spectra ESBLMay 1, 2017
K131804REMEL XPECT FLU A&BJuly 12, 2013
K092407REMEL SPECTRA MRSAOctober 8, 2010
K072827RPMI 1640 AGAR W/MOPS AND 2% GLUCOSENovember 26, 2007
K041951XPECT CLOSTRIDIUM DIFFICILE TOXIN A/BNovember 15, 2004
K033479PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAYFebruary 26, 2004
K031942XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020November 18, 2003
K031965XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020November 14, 2003
K031834XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAYNovember 10, 2003
K031565XPECT INFLUENZA A/BJuly 17, 2003
K013711BACTI-SWAB DRYNovember 26, 2001
K981391PAR-ONEJuly 14, 1998
K970832PYR SWABApril 24, 1997
K970834GRAM SWABApril 17, 1997
K970830REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISKApril 2, 1997
K970831REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISKApril 2, 1997
K970833INDOLE SWABApril 2, 1997
K965149A.C.T. IJanuary 22, 1997
K965152A.C.T. IIJanuary 22, 1997
K965150A.C.T. IVJanuary 22, 1997