Alinity i Free T3 Reagent Kit and Alinity I Total T3 Reagent Kit (2018-10-16)

Starting date:

October 16, 2018

Posting date:

November 2, 2018

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-68174

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  Reason
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  Affected products

Affected products

1. Alinity i Free T3 Reagent Kit
2. Alinity i Total T3 Reagent Kit

Reason

During Non-Conformance investigation a Reagent Cross Contamination (RCC) has been observed for the 6 and 2-

point ARCHITECT Free T3 and Total T3 assays on the i1000, when tested alongside assays containing poly-l-lysine (pll) e.g. ARCHITECT TSH. RCC has also been observed for the 2 and 6-point ARCHITECT free T3 and total T3 assays when tested on the i2000/i2000SR system and the Alinity i System.

Affected products