Recall Z-0382-2022 ยท MJH Legionella, Spp., Elisa
Clark Laboratories, Inc.
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
| Date | Oct 11, 2021 |
| Status | Terminated |
| Reason | Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay |
| Root cause | 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 |
| Quantity | 53 units |
| Distribution | OH, UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991074 | BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST Intracel Corp., Dec 21, 1999 |