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U.S. Department of Health and Human Services

Class 3 Device Recall Trinity Biotech HbA1c (GHb) Controls Kit,

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  Class 3 Device Recall Trinity Biotech HbA1c (GHb) Controls Kit, see related information
Date Initiated by Firm October 05, 2021
Date Posted December 01, 2022
Recall Status1 Terminated 3 on August 09, 2023
Recall Number Z-0350-2023
Recall Event ID 91054
510(K)Number K952720  
Product Classification Mixture, hematology quality control - Product Code JPK
Product Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
Code Information UDI/DI 0539151674808, Lot 12161
Recalling Firm/
Manufacturer		 Primus Corporation dba Trinity Biotech
4231 E 75th Ter
Kansas City MO 64132-2059
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JPK and Original Applicant = AALTO SCIENTIFIC LTD.
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