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SeroELISA Chlamydia IgG

SAVYON DIAGNOSTICS LTD · Model A111-01 · UDI-DI 07290001913147

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The SeroELISA Chlamydia IgG kit is intended for the determination of specific IgG antibody to Chlamydia in a single human serum sample or to evaluate paired sera, by an Enzyme-Linked Immunosorbent Assay (ELISA).

Recalls

Date	Firm	Reason
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2011-07-08	bioMerieux, Inc.	Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients.
2008-08-27	Calbiotech Inc	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,
2008-08-27	Calbiotech Inc	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,
2003-08-06	bioMerieux	Product's decrease in sensitivity may result in false negative results
2003-02-07	Thermo Biostar, Incorporated	Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.
2003-02-07	Thermo Biostar, Incorporated	Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.