HITACHI HICO Creatinine Jaffe Method, CREJ2 cobas (c 111, c 701/702, c 311/501/502), OCBAS INTEGRA 400 plus (2019-01-16)
- Starting date:
- January 16, 2019
- Posting date:
- March 1, 2019
- 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-69172
Affected Products
- HITACHI HICO Creatinine Jaffe Method, Rate-Blanked & Compensated (CREA)
- CREJ2 cobas c 111
- CREJ2, cobas c 701/702
- CREJ2 cobas c 311/501/502/ COBAS INTEGRA 400 plus
Reason
Creatinine Jaffe was found to interfere with glucose, pyruvate and ascorbate. No interference was found for the creatinine enzymatic assays on all platforms.
Affected products
-
HITACHI HICO Creatinine Jaffe Method, Rate-Blanked & Compensated (CREA)
Lot or serial number
21135801
22521601
23333001
24018201
24724601
25179801
28039501
29422901
33545001
Model or catalog number
11875418216
11875663216
11929941216
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. CREJ2 cobas c 111
Lot or serial number
23421901
26739801
31788801
35247501
Model or catalog number
05401755190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. CREJ2, cobas c 701/702
Lot or serial number
24327001
25635101
27623601
29187701
31403501
32683201
34583301
35712601
37008301
Model or catalog number
06407137190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
D. CREJ2 cobas c 311/501/502/ COBAS INTEGRA 400 plus
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
04810716190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY