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U.S. Department of Health and Human Services

Class 2 Device Recall ultra2 Genesys Variants Analyzer

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  Class 2 Device Recall ultra2 Genesys Variants Analyzer see related information
Date Initiated by Firm November 01, 2018
Create Date December 18, 2018
Recall Status1 Terminated 3 on June 21, 2022
Recall Number Z-0620-2019
Recall Event ID 81488
Product Classification Abnormal hemoglobin quantitation - Product Code GKA
Product ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Code Information all serial numbers
Recalling Firm/
Manufacturer		 Clark Laboratories, Inc. (dba,Trinity Biotech USA)
2823 Girts Rd
Jamestown NY 14701-9666
For Additional Information Contact
716-483-3851
Manufacturer Reason
for Recall		 lack of 510K
FDA Determined
Cause 2		 No Marketing Application
Action The firm initiated the recall by letter on 11/01/2018. The letter explained the problem and requested the return of the recalled items.
Quantity in Commerce 14 devices
Distribution IL, WV, NJ, AZ, MD, UT
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.
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