Bartels Legionella Urinary Antigen test recalled due to reagent contamination
Clark Laboratories is recalling the Bartels Legionella Urinary Antigen diagnostic test due to contamination in the test reagent that may cause invalid results. The affected test kits were distributed in Ohio and Utah.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving contaminated diagnostic test reagents. The source text does not report any illnesses or injuries. The hazard is theoretical—contamination may cause pipetting issues leading to potentially invalid test results. Per the rubric, recalls with low-risk contamination and theoretical hazards without reported harm are classified as Moderate.
Plain-English summary
Clark Laboratories, Inc. is recalling the Bartels Legionella Urinary Antigen diagnostic test kit (Product Code B1029-440). This test is used as an adjunct to culture for the presumptive diagnosis of past or current Legionnaires' disease by detecting Legionella pneumophila seragroup 1 antigen in human urine samples.
The recall was initiated because contamination of the conjugate may cause pipetting issues, which could lead to invalid assay results. The affected product is Lot #056 with an expiration date of November 28, 2022.
Fifty-three units of the recalled test kit were distributed in Ohio and Utah.
The recalled product
- 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
- Manufacturer
- Clark Laboratories, Inc.
- Category
- Medical Device — Diagnostic test
- Hazard
- reagent-contamination
- test-invalidity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065
Distribution
Distributed in 2 states:
- OH
- UT
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