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

• Reason
• Affected products

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