Tina-Quant IgA Gen2 (IgA-2) (2019-05-27)
- Starting date:
- May 27, 2019
- Posting date:
- June 21, 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-70225
Last updated: 2019-06-21
Affected Products
Tina-Quant IgA Gen2 (IgA-2)
Reason
There are potential calibration and quality control material failures for Tina-Quant IgA Gen. 2 assay (cat # 05219205190 lot 368756) when used on the cobas c 701-702 analyzers. This situation could lead to an under-recovery and/or over recovery of IgA in serum/plasma. This situation is only limited to a number of c packs, it can be detected by quality control or calibration failures of the affected reagent c packs.
Affected products
Tina-Quant IgA Gen2 (IgA-2)
Lot or serial number
368756
Model or catalog number
5219205190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY