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AMYL2 and LDHI2 for cobas C701 Analyzer (2015-05-21)
- Starting date:
- May 21, 2015
- Posting date:
- June 12, 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-53761
Recalled Products
A. AMYL2 for cobas C701 Analyzer
B. LDHI2 for cobas C701 Analyzer
Reason
Potential to obtain falsely low results without a flag in samples with high turbidity and high kinetic activity. This issue affects only LDHI2 and AMYL2 assays.
Affected products
A. AMYL2 for cobas C701 Analyzer
Lot or serial number
All lots.
Model or catalog number
5167027190
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. LDHI2 for cobas C701 Analyzer
Lot or serial number
All lots.
Model or catalog number
5169330190
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY