Clark Laboratories, Inc. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire'sClass IIOct 11, 2021Contamination of the conjugate may cause a pipetting issue w	Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay	Class IIDevices	Oct 11, 2021
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of MClass IIMar 17, 2021Positive Control may run high out of its assigned ISR range	Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retes	Class IIDevices	Mar 17, 2021