MalfunctionMHJ

ALEXON-TREND

Received Mar 27, 1998

Report 160307 · MDR key 160307

Device

Generic name

Cryptosporidium Microplate Assay

Manufacturer

Alexon-trend

Model number

Catalog number

540-9C, 540-24

Lot number

980402,980808,975006,(MORE)

Patient

Narrative

Description of Event or Problem

DIAGNOSTIC ASSAY FOR CRYPTOSPORIDIUM INFECTION IS PRODUCING FALSE-POSITIVE RESULTS. RESULTED IN REPORTING ABOUT 40 PTS WITH FALSE-POSITIVES SINCE 10/97.