Jamestown, NY, United States
Clark Laboratories, Inc. recalls
2 recalls recorded since 2018, most recently on 11 October 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 October 2021
- Terminated
- 9 March 2023
- Reason
- Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
- Distribution
- OH, UT
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0382-2022
- 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. Pro
Terminated Class II Medical devices
- Recall started
- 17 March 2021
- Terminated
- 29 June 2022
- Reason
- Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Ireland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1503-2021
- Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.