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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 340
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.
Part of a larger recall action
This product is one of 2 recalled by Primus Corporation dba Trinity Biotech under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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