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Cobas Taqman MTB Test
- Starting date:
- December 11, 2012
- Posting date:
- December 11, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices, Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-16825
Recalled Products
- Cobas Taqman MTB Test
Reason
The version 3.0 of the Cobas Taqman MTB test definition file product 2 in table 1 Cat. 0557445519 has an incorrect target elbow cutoff of 48 instead of 50. This test definition file TDF is used with the Cobas Taqman MTB test product 1 in table 1, Cat. 04803531190 patient.
Affected products
-
Cobas Taqman MTB Test
Lot or serial number
All Lots
Model or catalog number
04803531190
Companies
- Manufacturer
- PROche Molecular Systems Inc.