Lactate Gen. 2 in CSF and Bilirubin Total Gen 3 (BILT3) (2019-05-14)
- Starting date:
- May 14, 2019
- Posting date:
- June 7, 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-70119
Last updated: 2019-06-07
Affected Products
- Lactate Gen. 2 in CSF
- Bilirubin Total Gen 3 (BILT3)
Reason
Selected endogenous interferences in serum/plasma, urine and cerebrospinal fluid were assessed and new endogenous interferences claims for Bilirubin Total Gen. 3 and Lactate Gen. 2 used on COBAS INTEGRA 400 plus and COBAS c111 were found.
Affected products
A. Lactate Gen. 2 in CSF
Lot or serial number
33763601
35514701
37432001
37432101
38897701
Model or catalog number
3183700190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Bilirubin Total Gen 3 (BILT3)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5795397190
5795648190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY