MalfunctionLSR

BORRELIA BURGDORFERI IGG/IGM ELISA

Received Sep 3, 1998 · Event occurred Jul 2, 1998

Report MW1014503 · MDR key 185441

Device

Generic name

Lyme Disease Antibody Testing Kit

Manufacturer

Carter Wallace, Inc.

Model number

Catalog number

446580

Lot number

011

Product problems

False Negative Result

Patient

Narrative

Description of Event or Problem

LYME TESTING KITS FROM LOT#011 PERFORMED WITH REDUCED SENSITIVITY COMPARED TO OTHER LOTS. SOME PT SAMPLES, SUBSEQUENTLY TESTING POSITIVE FOR ANTIBODIES TO BORRELLA BURGDORFERI, WERE FOUND NEGATIVE USING THIS LOT OF KITS.