Tina-Quant IGG Gen 2 (2018-06-07)

Starting date:

June 7, 2018

Posting date:

June 22, 2018

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-67086

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  Reason
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  Affected products

Affected products

Tina-Quant IGG Gen 2

Reason

Internal investigation has revealed that when using the urine application of the Tina-quant IgG Gen.2 Assay (IgGu2) on Cobas C 311/501/502 analyzers with the reagent lot #24242601, a higher signal levels may cause a misfit of the calibration curve, resulting in over-recovery with a maximal bias of +37% for lower concentration samples.

Affected products