Z-0382-2022Class II

Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current...

Name: Z-0382-2022 Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current...
Creator: Clark Laboratories, Inc.
Published: 2021-10-11
License: https://open.fda.gov/license/

Trinity Biotech USA / initiated 2021-10-11 / Terminated / root cause: manufacturing process

FDA source

Clark Laboratories, Inc. began a recall of Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of... on 2021-10-11. FDA classified it as Class II and gives the reason as "Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0382-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-11
Posted: 2021-12-15
Terminated: 2023-03-09
Recalling firm: Trinity Biotech USA
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
Product code: MJH Legionella, Spp., Elisa
Reason for recall: Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Root cause tag: manufacturing process
FDA 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 in commerce: 53 units
Distribution: OH, UT
Product codes and lots: Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0382-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0382-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-15

Product code MJH

K991074Class IIBartels Legionella Urinary Antigen Elisa TestIntracel Corp. / cleared 1999-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)