A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052,
Summary
The FDA issued a Class III for A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Contro by Primus Corporation dba Trinity Biotech. Reason: The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unac.
Details
Source
Device Recall
External ID
Z-0349-2023
Action Date
2022-12-07
Status
Terminated
Category
device
Product Description
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
Lot/Code Info: Lot 12161
Quantity Affected: 340 kits
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. 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.
Distribution
Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-05
Company
Kansas City, MO
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Primus Corporation dba Trinity Biotech has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Primus Corporation dba Trinity Biotech) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Primus Corporation dba Trinity Biotech have FDA actions?
Primus Corporation dba Trinity Biotech has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0349-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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