Lower riskMedical device recall · FDA · Published October 11, 2021
Clark Laboratories Bartels Legionella Urinary Antigen Recall: Invalid Assays Risk
Clark Laboratories recalls Bartels Legionella Urinary Antigen test kits due to potential pipetting issues causing invalid results. Affected units include specific product codes and lots.
“Clark Laboratories Bartels Legionella Urinary Antigen Recall: Invalid Assays Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61697-clark-laboratories-bartels-legionella-urinary-antigen-recall-invalid-assays-risk. Based on FDA recall #Z-0382-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0382-2022%22&limit=1).
Clark Laboratories, Inc. recalled Bartels Legionella Urinary Antigen test kits on Oct. 11, 2021, due to potential contamination causing invalid assays, the FDA said. The voluntary Class II recall involved 53 units distributed in Ohio and Utah.
How to tell if you have it
Brand: Clark Laboratories
Product: Bartels Legionella Urinary Antigen
Product Code: B1029-440
Lot #: 056
Expiration Date: 2022-11-28
UDI: 05391516744065
The hazard
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay, according to the FDA. The product is used for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine.
Context
GovInfoNow's records show Clark Laboratories, Inc. has one other recall on record since March 17, 2021, involving a measles IgM test kit due to potential invalid results. Other recent recalls of similar products include GET TESTED Urinary Tract Infection Test Recall (Nov. 3, 2025), Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025), and Sperm Ab ELISA Test Kit Recall (July 2, 2026).
How to tell if you have this one
Check for product code B1029-440 and lot number 056. The expiration date is November 28, 2022, and the unique device identifier is 05391516744065.
Brand
Clark Laboratories
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product code (B1029-440), lot number (056), and expiration date (November 28, 2022).
Where it went and when
Where it was distributed
Distributed in Ohio and Utah.
Listed by the agency
Not listed
FDA distribution: “OH, UT” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Ohio, Utah.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0382-2022 (October 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0382-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.