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U.S. Department of Health and Human Services

Class 3 Device Recall Captia Measles IgM

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  Class 3 Device Recall Captia Measles IgM see related information
Date Initiated by Firm July 11, 2016
Date Posted September 12, 2016
Recall Status1 Terminated 3 on May 09, 2017
Recall Number Z-2782-2016
Recall Event ID 74932
510(K)Number K140455  
Product Classification Enzyme linked immunoabsorbent assay, rubeola IgM - Product Code PCL
Product Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Code Information Lot Number 2326060-043, Expiration Date 31 May 2017 
Recalling Firm/
Manufacturer		 Clark Laboratories, Inc. (dba,Trinity Biotech USA)
2823 Girts Rd
Jamestown NY 14701-9666
For Additional Information Contact Kathy Ames
716-483-3851
Manufacturer Reason
for Recall		 The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Recall notification letters (dated 7/11/2016) were sent by FedEx on 7/11/2016. Customers were instructed to discontinue use of any remaining inventory (discard on site if any remaining). Customers were also advised that if the test resulted in a valid run, such that all Controls and Calibrator met the Quality Control Criteria as stated in the package insert, the patient results can be reported and a re-evaluation of patient results is not necessary. For questions, please contact Trinity Biotech's Help Desk at 1-800-325-3424 Option #3.
Quantity in Commerce US: 6 kits, Foreign: 50 kits
Distribution Distribution to US nationwide including California, and China (Hong Kong).
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 = PCL and Original Applicant = TRINITY BIOTECH USA
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