Medical diagnostic control kit recalled for out-of-range quality control results
Primus Corporation recalls Trinity Biotech HbA1c Control Kits because Control Level I material produces out-of-range results that cause analyzer malfunction and testing delays, potentially delaying patient results.
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 an FDA Class III recall with no reported illnesses or injuries. The hazard is functional—control material producing out-of-range results causes the analyzer to malfunction and stop testing, delaying patient results. Because no actual harm has been reported and the product is classified as Class III, the severity is Moderate.
Plain-English summary
Primus Corporation dba Trinity Biotech is recalling Trinity Biotech HbA1c (GHb) Control Kits (REF 01-04-0020, Part number 05-01-0040B) affecting 182 kits with Lot 12161. The Control Level I material in these kits is producing results that exceed the upper limit of the acceptable range after approximately three months of use.
When the control material produces these out-of-range results, the analyzer generates an error code that stops further testing and nullifies associated patient samples. This results in delays in obtaining patient test results and could lead to delays in therapeutic modifications based on those results.
The affected kits were distributed internationally to laboratories in Turkey, India, Romania, Thailand, Vietnam, South Korea, Peru, Pakistan, Austria, United Arab Emirates, Chile, and Italy.
Laboratories and healthcare facilities using affected kits should discontinue use and contact Primus Corporation for replacement kits.
The recalled product
- Product
- Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
- Manufacturer
- Primus Corporation dba Trinity Biotech
- Affected units
- 182
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 (2)
- UDI/DI 0539151674808
- 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Primus Corporation dba Trinity Biotech
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