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ELECSYS N-MID-OSTEOCALCIN (2017-11-16)
- Starting date:
- November 16, 2017
- Posting date:
- November 30, 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-65284
Affected products
ELECSYS N-MID-OSTEOCALCIN
Reason
An erroneous concentration was used in the Elecsys N-MID Osteocalcin method sheet (version 1.0) for cobas e801 under section "limitations-interference" where the potential interference of "endogenous substances" is listed. In the column "concentration tested" for hemoglobin "= 311 mmol/l" is written instead of the correct concentration of "= 0.311 mmol/l".
Affected products
ELECSYS N-MID-OSTEOCALCIN
Lot or serial number
All lots
Model or catalog number
7027591190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY