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Cedia TDM Assay - Tobramycin II (2013-10-16)
- Starting date:
- October 16, 2013
- Posting date:
- April 22, 2014
- 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-39157
Recalled Products
Cedia TDM Assay - Tobramycin II
Reason
The reconstituted reagents do not maintain 30 days reconstituted stability. The instability of the reconstituted reagents may cause higher recovery of samples.
Affected products
Cedia TDM Assay - Tobramycin II
Lot or serial number
60169764
Model or catalog number
100018
Companies
- Manufacturer
-
Microgenics Corporation
46360 Fremont Blvd.
Fremont
94538
California
UNITED STATES