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U.S. Department of Health and Human Services

Class 2 Device Recall Bartels Legionella Urinary Antigen

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  Class 2 Device Recall Bartels Legionella Urinary Antigen see related information
Date Initiated by Firm October 11, 2021
Create Date December 15, 2021
Recall Status1 Terminated 3 on March 09, 2023
Recall Number Z-0382-2022
Recall Event ID 89088
510(K)Number K991074  
Product Classification Legionella, spp., elisa - Product Code MJH
Product Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine.
Product Code: B1029-440
Code Information Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065
Recalling Firm/
Manufacturer		 Clark Laboratories, Inc.
2823 Girts Rd
Jamestown NY 14701-9666
For Additional Information Contact SAME
716-483-3851
Manufacturer Reason
for Recall		 Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
FDA Determined
Cause 2		 Material/Component Contamination
Action Trinity Biotech notified customers by Customer Recall letter dated 10/11/21 states reason for recall, health risk and action to take: Customers are instructed to complete the attached fax back form indicating how many of this kit lot you have in your inventory and you will receive replacement from another lot. A thorough investigation into the root cause has been initiated and any corrective/preventive actions will be implemented as appropriate. If you have any questions or comments arising from this customer communication, the Trinity Biotech Help Desk is ready to answer your questions (800-325-3424, option 2). to destroy the kit and offered replacement product of a different lot. Any results obtained from a valid assay may be reported do not require repeat testing.
Quantity in Commerce 53 units
Distribution OH, 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.
510(K) Database 510(K)s with Product Code = MJH and Original Applicant = INTRACEL CORP.
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