Roche Diagnostics Assays (2018-11-18)
- Starting date:
- November 18, 2018
- Posting date:
- January 11, 2019
- 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-68744
Affected products
- COBAS Integra Lactate Gen 2 (LACT2)
- IGM-2 (TINA-QUANT IGM GEN.2) FOR USE ON C701 ANALYZER
- IGM-2 (TINA-QUANT IGM GEN.2) ROCHE/HITACHI 904/911/912/917 AN MOD. P ANALY.
- IGM-2 (TINA-QUANT IGM GEN.2) FOR USE ON COBAS C SYSTEMS ANALYZERS
- LACT2 (LACTATE GEN.2) FOR COBAS C701 ANALYZER
- BILIRUBIN TOTAL GEN.3 (BILT3)
Reason
During internal study, selected endogenous drug interferences in serum/plasma, urine and cerebrospinal fluid were assessed on all Roche tests and new endogenous interferences claims for three tests (BIL-T Gen.3, IGM Gen2 and LACT Gen.2) were found.
Affected products
A. COBAS Integra Lactate Gen 2 (LACT2)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
03183700190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. IGM-2 (TINA-QUANT IGM GEN.2) FOR USE ON C701 ANALYZER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
05220726190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. IGM-2 (TINA-QUANT IGM GEN.2) ROCHE/HITACHI 904/911/912/917 AN MOD. P ANALY.
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
03507041190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
D. IGM-2 (TINA-QUANT IGM GEN.2) FOR USE ON COBAS C SYSTEMS ANALYZERS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
03507190190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
E. LACT2 (LACTATE GEN.2) FOR COBAS C701 ANALYZER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
05171881190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
F. BILIRUBIN TOTAL GEN.3 (BILT3)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
05795320190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY