CLASS III Device recall · Reported 7 Dec 2022 · FDA Enforcement Report

Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II) recalled

Primus is recalling Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II). The recall was initiated on 5 Oct 2021 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI/DI 0539151674808, Lot 12161

Quantity recalled182 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0350-2023
FDA event ID: 91054
Recalling firm: Primus, Kansas City, MO
Classification: Class III
Status: Terminated
Recall initiated: 5 Oct 2021
FDA classified: 1 Dec 2022
Reported: 7 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Oct 2021	Recall initiated by company
1 Dec 2022	Classified by FDA	+422 days
7 Dec 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

Questions about this recall

Is Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II) recalled?

Yes. Primus recalled Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II) on 5 Oct 2021. The recall is Class III and its status is Terminated. Recall number Z-0350-2023.

Why was it recalled?

Which lots are affected?

UDI/DI 0539151674808, Lot 12161

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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