Elecsys Insulin & total P1NP (2020-05-13)
- Starting date:
- May 13, 2020
- Posting date:
- June 19, 2020
- 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-73355
Last updated: 2020-06-19
Affected Products
- Elecsys Insulin
- Elecsys total P1NP
Reason
In the course of the harmonization activities of Method Sheets for cobas e 60x/ cobas e 411 and cobas e 801 and for preparation to the upcoming EU IVD regulation : changes and adjustments are applied to the new Method Sheets versions, including New interference claims for Elecsys Insulin and total P1NP on our cobas e 60x/ cobas e 411 analyzers. We were informed by our Manufacturer on 08-MAY-2020.
Affected products
A. Elecsys Insulin
Lot or serial number
- 37847601
- 37847602
- 37847603
- 37847604
- 43022301
- 43022302
- 43022303
Model or catalog number
- 12017547122
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Elecsys total P1NP
Lot or serial number
- 13441601
- 39401401
- 45155401
Model or catalog number
- 3141071190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY