Reported Dec 22, 2021 · Terminated
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current…
Clark Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Clark Laboratories, Inc. · 2823 Girts Rd · Jamestown, NY · 14701-9666
Is this the product you have?
- 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 CodeB1029-440
- Lot codes and dates
- Lot # 056
- Expiration Date2022-11-28
- UDI05391516744065
- Amount recalled
- 53 units
Where it was sold
Why it was recalled
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
This product could cause temporary or reversible health problems — stop using it.
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