Primus Corporation dba Trinity Biotech: Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis

Is my product affected?

Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis

• UPC 0539151674808

Check against the official notice below — it lists the full affected range.

What happened

Primus Corporation, doing business as Trinity Biotech, recalled 182 kits of Trinity Biotech HbA1c (GHb) Controls Kit (Levels I & II) distributed to Turkey, India, Romania, Thailand, Vietnam, South Korea, Peru, Pakistan, Austria, UAE, Chile, and Italy. The Control Level I material in these kits was showing results exceeding the upper acceptable range after three months of use. When the Control Level I value became unacceptable, the analyzer generated an error code that stopped further testing and nullified associated patient samples.

This defect resulted in delays in patient test results and potential delays in therapeutic modifications. The affected product has Lot number 12161 and UDI/DI 0539151674808. The source document does not specify what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.

Details from the source

Reason for recall: The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications. Distribution: Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy. Quantity: 182 kits Lot/code info: UDI/DI 0539151674808, Lot 12161

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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