Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)

Chlamydia Test

Distribution without premarket approval/clearance.

VIDAS Chlamydia test kits

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

Chlamydia Pneumoniae IgG ELISA 96 Well Kit, Catalog Number: CP083G

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.

Chlamydia Pneumoniae IgM ELISA 96 Well Kit, Catalog Number: CP095M

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.

VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use

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

Chlamydia OIA. For in vitro diagnostic use,

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

Chlamydia OIA. For in vitro diagnostic use.

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