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
Reported: December 22, 2021 Initiated: October 11, 2021 #Z-0382-2022
Product Description
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 for Recall
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Details
- Recalling Firm
- Clark Laboratories, Inc.
- Units Affected
- 53 units
- Distribution
- OH, UT
- Location
- Jamestown, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Clark Laboratories, Inc.. Units affected: 53 units.
Why was this product recalled? ▼
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 22, 2021. Severity: Moderate. Recall number: Z-0382-2022.
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