Recall archive / FDA device enforcement
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnair... — FDA record Z-0382-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 11, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
- Classification
- Class II
- Recalling firm
- Clark Laboratories, Inc.
- Quantity
- 53 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0382-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
OH, UT
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 22, 2021
- Recall initiation date
- Oct 11, 2021
- Center classification date
- Dec 15, 2021
- Termination date
- Mar 9, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.