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Elecsys Anti-HAV IgM
- Starting date:
- March 16, 2017
- Posting date:
- April 4, 2017
- 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-62904
Reason
Specific lots of the Elecsys Anti-HAV IgM assay (# 159616-xx, 181769-xx) may cause failed calibrations if used on the Cobas E411 analyzer.
Affected products
Elecsys Anti-HAV IgM
Lot or serial number
15961601
15961602
18176901
18176902
Model or catalog number
11820591122
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY