Discs, Strips And Reagents, Microorganism Differentiation
Microbiology · 21 CFR 866.2660
Recent MDR events
211 adverse event reports on file
- BD BBL¿ VOGES-PROSKAUER A REAGENT DROPPERSApr 1, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00594
- BD BBL¿ 10% POTASSIUM HYDROXIDE REAGENT DROPPERSJun 6, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-00537
- BD BBL¿ DMACA INDOLE REAGENT DROPPERJun 2, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-00532
- BD BBL¿ TAXO¿ ANov 22, 2024MalfunctionBecton Dickinson Caribe Ltd.2647876-2024-00161
- RAPID ID 32 STREPJul 24, 2024MalfunctionBiomérieux Sa9615754-2024-00011
- BD BBL¿ METHYLENE BLUE LOEFFLER STAIN DROPPERFeb 7, 2024MalfunctionBecton Dickinson & Co. (sparks)1119779-2024-00085
- RAPID ID 32 STREP 25STRIPS - 32600Nov 10, 2023MalfunctionBiomérieux Sa9615754-2023-00051
- BD BBL¿ DRYSLIDE¿ OXIDASEOct 17, 2023MalfunctionBecton Dickinson Caribe Ltd.2647876-2023-00251
- API LISTERIA 10STRIPS+10MEDIAOct 10, 2023MalfunctionBiomerieux, Sa9615754-2023-00041
- API LISTERIA 10STRIPS+10MEDIAOct 10, 2023MalfunctionBiomerieux, Sa9615754-2023-00042
Event type breakdown
Recalls
21 recall events for this product code
- Biomerieux IncOpen, ClassifiedJan 4, 2023
API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0783-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0805-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0806-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0807-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
API VP1 VP2 REAGENTS, CATALOG 70422
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0808-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
API NIT1 NIT2 REAGENTS, CATALOG 70442
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0809-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
API JAMES 2AMP, CATALOG 70542
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0810-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0811-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0832-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0862-2023 · View FDA record ↗
Registered firms
116 firms currently registered for this product code
Remel, Inc.
LENEXA, KS, US
Rr Donnelley Global Turnkey Solutions
Juarez Chihuahua, MX
Remel Europe Ltd
DARTFORD, KENT, GB
Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE, GB
Hospital & Homecare Imp. & Exp. Co., Ltd
NANJING Jiangsu, CN
Ethos Biosciences, Inc.
Logan Township, NJ, US
Changchun Lyz Technology Co.,ltd
Changchun City Jilin, CN
510(k) clearances
244 clearances for this product code
- Ameritek Research, LLCSep 1, 2005
K050352 · IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT
- Remel, Inc.Apr 24, 1997
K970832 · PYR SWAB
- Remel, Inc.Apr 17, 1997
K970834 · GRAM SWAB
- Remel, Inc.Apr 2, 1997
K970833 · INDOLE SWAB
- Microbiologics, Inc.Feb 6, 1997
K970009 · LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
- Innovative Diagnostic Systems, Inc.Oct 8, 1996
K962966 · IDS RAPID CB PLUS SYSTEM
- Hardy DiagnosticsJun 17, 1996
K961191 · COLISCREEN
- Hardy DiagnosticsApr 18, 1996
K960996 · M. CAT BUTYRATE DISK