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Terminated

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

FDA Recall Z-0350-2023 · Posted 2022-12-01

Recalling FirmPrimus Corporation dba Trinity Biotech
Recall StatusTerminated
Product CodeJPK
Date Initiated2021-10-05
Date Terminated2023-08-09
Product Quantity182 kits

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.

Firm Action

The firm sent an Urgent Filed Safety Notice their consignees on 10/05/2021 by mail. The notice explained the issue, risk and requested the destruction of of the affected devices.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952720AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & IIAalto Scientific, Ltd. · 1995-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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