HCG STAT elecsys cobas e 100 V2, Troponin I Elecsys cobas e 100, Troponin T hs STAT Elecsys, cobas e 100, Myoglobin STAT Elecsys cbas e 100 (2018-06-05)
- Starting date:
- June 5, 2018
- Posting date:
- July 6, 2018
- 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-67116
Affected products
A. HCG STAT Elecsys cobas e 100 V2
B. Troponin I STAT Elecsys cobas e 100
C. Troponin T hs STAT Elecsys cobas e 100
D. Myoglobin STAT Elecsys cobas e 100
Reason
It was found that due to a software design error, decreased recovery is obtained if samples are diluted using automatic dilution function on Cobas E 601 and Cobas E 602 with dilution ratios of 1:5 or higher for the following stat applications.
Affected products
A. HCG STAT Elecsys cobas e 100 V2
Lot or serial number
24867501
24867502
24867503
31981401
Model or catalog number
03300811190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Troponin I STAT Elecsys cobas e 100
Lot or serial number
Not applicable
Model or catalog number
05094798190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. Troponin T hs STAT Elecsys cobas e 100
Lot or serial number
24518001
24518003
26765401
26765403
Model or catalog number
05092728190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
D. Myoglobin STAT Elecsys cobas e 100
Lot or serial number
25388301
Model or catalog number
11820788122
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY