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ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING (2015-11-26)
- Starting date:
- November 26, 2015
- Posting date:
- January 14, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-56596
Affected Products
A. ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - PIPERACILLIN/TAZOBACTAM
B. ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - PIP/TAZO/CON-4
Reason
On October 27th, 2015, a customer reported a low Mic on Etest Piperacillin/Tazobactam (4 ug/ml) PTC-256 single pack (lot 1004271120). The customer obtained erroneous results (false susceptible) on Etest with broth-micro dilution reference method.
Affected products
A. ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - PIPERACILLIN/TAZOBACTAM
Lot or serial number
- 1002092270
- 1002276210
- 1002375410
- 1002482640
- 1002995820
- 1003105180
- 1003416920
- 1003699550
- 1003980200
- 1004180840
- 1004276460
- 1004398470
Model or catalog number
521418
Companies
- Manufacturer
-
Biomerieux Inc.
595 Anglum Road
Hazelwood
63042
Missouri
UNITED STATES
B. ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - PIP/TAZO/CON-4
Lot or serial number
- 1001936360
- 1002488490
- 1003069230
- 1003276060
- 1003415090
- 1003697470
- 1003977300
- 1004178060
- 1004271120
- 1004331500
Model or catalog number
412434
Companies
- Manufacturer
-
Biomerieux Inc.
595 Anglum Road
Hazelwood
63042
Missouri
UNITED STATES