Recalls for Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)

Distribution without premarket approval/clearance.

Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients.

The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.

The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.

Product's decrease in sensitivity may result in false negative results

Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.

Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.