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COBAS INTEGRA TINA-QUANT SOLUBLE TRANSFERRIN RECE (2015-07-03)
- Starting date:
- July 3, 2015
- Posting date:
- August 10, 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-54532
Affected Products
A. COBAS INTEGRA TINA-QUANT SOLUBLE TRANSFERRIN RECE
Reason
Roche received a customer complaint regarding elevated imprecision and too high recovery of STFR control set level 1 and DUP alarms during calibration with the reagent TQ Soluble Transferrin Receptor (STFR). The issue of elevated imprecision was confirmed by internal investigations on lot #606449 on Cobas C501 showed elevated imprecision of up to 8.9%. The other current reagent lots are not affected by this issue
Affected products
A. COBAS INTEGRA TINA-QUANT SOLUBLE TRANSFERRIN RECE
Lot or serial number
60644901
Model or catalog number
20763454122
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY