Enterococcus Faecalis Derived from ATCC 51299 (2020-02-21)
- Starting date:
- February 21, 2020
- Posting date:
- April 15, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72731
Last updated: 2020-04-15
Affected Products
Enterococcus Faecalis Derived from ATCC 51299
Reason
High level gentamicin synergy value was out of specification (sensitive) when analyzed on the vitek 2 AST-GP67 card, and these lots also failed the disk diffusion method used for product release.
Affected products
Enterococcus Faecalis Derived from ATCC 51299
Lot or serial number
- 959-97-1
- 959-94-1
- 959-94-2
- 959-94-3
- 959-95-1
- 959-95-2
- 959-96-1
- 959-96-3
- 959-96-4
- 959-97-4
Model or catalog number
- 0959K
- 0959L
- 0959P
Companies
- Manufacturer
-
Microbiologics, Inc.
200 Cooper Ave. N
St. Cloud
56303
Minnesota
UNITED STATES