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Vitek 2 Systems and Compact Systems (2017-11-21)
- Starting date:
- November 21, 2017
- Posting date:
- December 8, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65334
Affected products
A. VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST C
B. VITEK 2 COMPACT 60 SYSTEM - SUSCEPTIBILITY TEST C
C. VITEK 2 SYSTEM - SUSCEPTIBILITY TEST CARDS
Reason
During documentation review for three new VITEK 2 AST GP Test Cards, it was discovered that there is a Cefoxitin screen (oxsf01n) "test by alternative method" limitation for staphylococcus pseudintermedius that is incorrect in, or missing from, various package inserts.
Affected products
A. VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST C
Lot or serial number
All lots
Model or catalog number
22226
22233
22340
22359
415 670
Companies
- Manufacturer
-
Biomerieux Inc.
100 Rudolphe Street
Durham
27712
North Carolina
UNITED STATES
B. VITEK 2 COMPACT 60 SYSTEM - SUSCEPTIBILITY TEST C
Lot or serial number
All lots
Model or catalog number
22 340
22226
22233
22359
415 670
Companies
- Manufacturer
-
Biomerieux Inc.
100 Rudolphe Street
Durham
27712
North Carolina
UNITED STATES
C. VITEK 2 SYSTEM - SUSCEPTIBILITY TEST CARDS
Lot or serial number
All lots
Model or catalog number
22 340
22226
22233
22359
415 670
Companies
- Manufacturer
-
Biomerieux Inc.
100 Rudolphe Street
Durham
27712
North Carolina
UNITED STATES