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COBAS S201 System Pooling and Data Management (PDM) V3.0.35 (2015-04-20)
- Starting date:
- April 20, 2015
- Posting date:
- May 21, 2015
- 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-53427
Recalled Products
A. COBAS S201 System Pooling and Data Management (PDM)
Reason
The pooling software can create pools containing more or less donors than originally intended during simultaneous pooling runs for both the Cobas TaqScreen MPX and Cobas TaqScreen WNV tests, when the donor tube carrier on the Hamilton STAR/STARlet pipettor is missing a donor tube in any position within the donor tube carrier.
Affected products
A. COBAS S201 System Pooling and Data Management (PDM)
Lot or serial number
All lots.
Model or catalog number
6660975190
Companies
- Manufacturer
-
Roche Molecular Systems
Inc
1080 US Highway 202
New Jersey
UNITED STATES