FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0382-2022
- Recalling firm
- Clark Laboratories, Inc.
- 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
- Status
- Terminated
- Initiated
- 2021-10-11
- Posted
- not on file
- Terminated
- 2023-03-09
- 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 (800-325-3424, 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
- 53 units
- Distribution
- OH, UT
- Lot, serial or model codes
- Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065
- 510(k) numbers
- ["K991074"]
- PMA numbers
- not on file
- Product code
- MJH
- Firm FEI
- 1318354
- Firm city
- Jamestown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28