CLASS II Device recall · Reported 22 Dec 2021 · FDA Enforcement Report
Bartels Legionella Urinary Antigen- an adjunct to culture recalled
Clark Laboratories is recalling Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis, distributed in Ohio, Utah. The recall was initiated on 11 Oct 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0382-2022
- FDA event ID
- 89088
- Recalling firm
- Clark Laboratories, Jamestown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Oct 2021
- FDA classified
- 15 Dec 2021
- Reported
- 22 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Oct 2021 | Recall initiated by company | |
| 15 Dec 2021 | Classified by FDA | +65 days |
| 22 Dec 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
OH, UT
Questions about this recall
Why was it recalled?
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Which lots are affected?
Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065
Where was it sold?
OH, UT
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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