Z-0350-2023Class III

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

Name: Z-0350-2023 Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c...
Creator: Primus Corporation dba Trinity Biotech
Published: 2021-10-05
License: https://open.fda.gov/license/

Trinity Biotech (Primus Corporation dba Trinity Biotech) / initiated 2021-10-05 / Terminated / root cause: manufacturing process

FDA source

Primus Corporation dba Trinity Biotech began a recall of Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis on 2021-10-05. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0350-2023
Classification: Class III
Status: Terminated
Initiated: 2021-10-05
Posted: 2022-12-01
Terminated: 2023-08-09
Recalling firm: Trinity Biotech (Primus Corporation dba Trinity Biotech)
Product: Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
Product code: JPK Mixture, Hematology Quality Control
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 182 kits
Distribution: Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
Product codes and lots: UDI/DI 0539151674808, Lot 12161

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0350-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0349-2023	Class III	Terminated	Voluntary: Firm initiated	2022-12-07	2022-12-01
Z-0350-2023	Class III	Terminated	Voluntary: Firm initiated	2022-12-07	2022-12-01

Product code JPK

K952720Class IIAalto Scientific Ltd. Glycated Hemoglobin Control Levels I & IIAalto Scientific, Ltd. / cleared 1995-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)