Hemoglobin A1c Control Material Produces Incorrect Test Results
A. MENARINI diagnostics hemoglobin A1c control materials (Lot 12161) are producing incorrect results that cause analyzer errors and prevent diagnostic testing. Facilities using this lot should discontinue use and contact the manufacturer.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class III recall with no reported illnesses or injuries. The hazard is a functional defect in diagnostic control materials causing analyzer errors and test delays, rather than a direct safety threat. Class III recalls are typically scored 1 or 2; this is 2 due to the impact on critical diagnostic testing functionality.
Plain-English summary
This recall involves A. MENARINI diagnostics Hb 9210 PREMIER hemoglobin A1c control materials used to verify the accuracy of hemoglobin A1c testing analyzers. The affected lot (12161) contains 340 kits distributed to facilities in Turkey, India, Romania, Thailand, Vietnam, South Korea, Peru, Pakistan, Austria, UAE, Chile, and Italy.
The Control Level I material in this lot is producing values that exceed the acceptable upper limit after approximately three months of use. When the analyzer detects these unacceptable control values, it generates an error code that stops all further testing on that instrument. This causes the analyzer to reject associated patient samples and prevents diagnostic results from being reported.
This issue affects clinical laboratories and healthcare facilities using this specific lot to perform hemoglobin A1c tests on patients with diabetes. The test failures and result delays can prevent timely diagnostic reporting and may delay necessary therapeutic modifications for patients requiring diabetes monitoring.
Facilities with this lot should immediately discontinue use and contact Primus Corporation dba Trinity Biotech for instructions on replacement control materials. Healthcare providers should not rely on test results from affected analyzers until the control materials have been replaced.
The recalled product
- Product
- A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis
- Manufacturer
- Primus Corporation dba Trinity Biotech
- Hazard
- inaccurate-results
- test-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 12161
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27
- ModerateMedtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
FDA (Devices) · 2026-05-27
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- HighIntegris-Allura X-ray systems with degraded deaeration hoses recalled
FDA (Devices) · 2026-05-27