GIARDIA II

TECHLAB, INC. · Model PT5012 · UDI-DI 00857031002295

MHI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children.

Recalls

Date	Firm	Reason
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2025-03-24	MEDLINE INDUSTRIES, LP - Northfield	A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.
2008-08-11	Remel, Inc	Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive
2004-02-23	Genzyme Diagnostics	False Positive results.
2003-12-09	Remel, Inc.	The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.
2002-11-21	Remel, Inc.	The conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause t

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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.