Supplement, Culture Media
Microbiology · 21 CFR 866.2450
Recent MDR events
19 adverse event reports on file
- BD DIFCO¿ D-GALACTOSESep 19, 2023MalfunctionBecton, Dickinson & Co. (sparks)1119779-2023-01019
- BD DIFCO¿ GELATINSep 15, 2023MalfunctionBecton, Dickinson & Co. (sparks)1119779-2023-01001
- BD DIFCO¿ GELATINSep 15, 2023MalfunctionBecton, Dickinson & Co. (sparks)1119779-2023-01003
- BD DIFCO¿ EY TELLURITE ENRICHMENTAug 9, 2023MalfunctionBecton Dickinson & Co. (sparks)1119779-2023-00864
- BD BBL¿ ISOVITALEX¿ ENRICHMENTApr 26, 2023MalfunctionBecton, Dickinson & Co. (sparks)1119779-2023-00480
- BD DIFCO¿ OXGALL (DEHYDRATED FRESH BILE)Jan 19, 2023MalfunctionBecton, Dickinson & Co. (sparks)1119779-2023-00039
- BD BACTO¿ AGARJan 5, 2023MalfunctionBecton, Dickinson & Co. (sparks)1119779-2023-00002
- BD DIFCO¿ AGAR, GRANULATEDSep 19, 2022MalfunctionBecton, Dickinson & Co. (sparks)1119779-2022-01209
- BD DIFCO¿ AGAR, GRANULATEDJun 6, 2022MalfunctionBecton, Dickinson & Co. (sparks)1119779-2022-00820
- BD BBL¿ EGG YOLK TELLURITE ENRICHMENTFeb 14, 2022MalfunctionBecton, Dickinson & Co. (sparks)1119779-2022-00232
Event type breakdown
Recalls
6 recall events for this product code
- Acumedia Manufacturers, Inc.TerminatedJun 1, 2017
Beef Extract Powder, Acumedia PN 7228
Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019.
Z-2214-2017 · View FDA record ↗ - Remel IncTerminatedMar 2, 2015
Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hamps
Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.
Z-1232-2015 · View FDA record ↗ - Remel IncTerminatedDec 12, 2014
Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials.
Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.
Z-0578-2015 · View FDA record ↗ - Remel IncTerminatedNov 10, 2014
Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg.
Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.
Z-0200-2015 · View FDA record ↗ - Remel IncTerminatedFeb 26, 2014
Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingsto
The product may contain high levels of microbial contamination
Z-1112-2014 · View FDA record ↗ - Remel IncTerminatedFeb 11, 2013
The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and
The product may contain low level microbial contamination which could result in incorrect results.
Z-0801-2013 · View FDA record ↗
Registered firms
27 firms currently registered for this product code
Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE, GB
Remel, Inc.
LENEXA, KS, US
Incell Corporation, Llc
SAN ANTONIO, TX, US
Calibrescientific Us, Inc.
VANCOUVER, WA, US
Trinity Biotech Usa
Jamestown, NY, US
Belair Instrument Co, Llc D/b/a Avantik
Pine Brook, NJ, US
Legacy Biologicals
Baltimore, MD, US
Elitechgroup Microbio
SIGNES Var, FR
Hardy Diagnostics
Orcutt, CA, US
Himedia Laboratories Private Limited
DOMBIVLI, THANE Maharashtra, IN
Himedia Laboratories Private Limited
NASHIK Maharashtra, IN
Lonza Walkersville, Inc.
WALKERSVILLE, MD, US
Pro-lab Incorporated
Richmond Hill Ontario, CA
Lonza Verviers Srl.
Verviers Liege, BE
Medical Wire And Equipment Co. Ltd.
CORSHAM, WILTSHIRE, GB
510(k) clearances
70 clearances for this product code
- Alpha-Tec Systems, Inc.May 25, 1988
K881949 · ATS NAC-PAC SET
- Alpha-Tec Systems, Inc.May 13, 1988
K881879 · ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42
- Acumedia Manufacturers, Inc.Apr 18, 1988
K881566 · HEMOGLOBIN POWDER
- Hazleton Research Products, Inc.Jun 10, 1986
K861997 · PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE
- Flow Laboratories, Inc.May 20, 1986
K861824 · GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)
- Flow Laboratories, Inc.May 20, 1986
K861823 · GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)
- Flow Laboratories, Inc.May 20, 1986
K861791 · PENICILLIN-STREPTOMYCIN-FUNGIZONE
- Micro-Bio-LogicsFeb 20, 1986
K855172 · KWI (TM) G-CO/TWO