Recall Z-0382-2022— Clark Laboratories, Inc.
Class II · Terminated
Class II FDA medical device recall by Clark Laboratories, Inc., initiated 2021-10-11, terminated 2023-03-09. It names one FDA 510(k) clearance: K991074. 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.
- Recalling firm
- Clark Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-10-11
- Terminated
- 2023-03-09
- Firm location
- Jamestown, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.