Giardia Spp.
Microbiology · 21 CFR 866.3220
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
6 recall events for this product code
- GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Parasite Test
Distribution without premarket approval/clearance.
Z-0748-2026 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedMay 2, 2025
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
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.
Z-1719-2025 · View FDA record ↗ - Remel, IncTerminatedSep 19, 2008
Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic Use.
Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive
Z-2432-2008 · View FDA record ↗ - Remel, Inc.TerminatedAug 17, 2004
ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496.
The conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause the dropper tips to become plugged. Quality control testing indicated that the reagents were still performing as intended, including the conjugates.
Z-1374-04 · View FDA record ↗ - Remel, Inc.TerminatedAug 17, 2004
ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496.
The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.
Z-1375-04 · View FDA record ↗ - Genzyme DiagnosticsTerminatedJul 20, 2004
Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits.
False Positive results.
Z-0770-04 · View FDA record ↗
Registered firms
32 firms currently registered for this product code
Remel, Inc.
LENEXA, KS, US
Techlab, Inc.
Radford, VA, US
Drg Instruments Gmbh
MARBURG Hesse, DE
Techlab, Inc.
BLACKSBURG, VA, US
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
Medical Chemical Corporation
TORRANCE, CA, US
Acro Biotech Inc.
Montclair, CA, US
Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE, GB
Remel Europe Ltd
DARTFORD, KENT, GB
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Drg International, Inc.
Springfield, NJ, US
Sekisui Diagnostics, Llc
SAN DIEGO, CA, US
Biomerica De Mexico, S.a. De C.v.
MEXICALI Baja California, MX
Immunocentrix Corporation
Canoga Park, CA, US
Meridian Bioscience, Inc.
Cincinnati, OH, US
510(k) clearances
27 clearances for this product code
- Trinity BiotechMar 1, 2013
K120001 · UNIGOLD GIARDIA
- Techlab Inc., Corporate Research CenterAug 18, 2011
K103673 · GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK
- Ivd Research, Inc.Jan 14, 2009
K081064 · GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
- Remel, Inc.Nov 18, 2003
K031942 · XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
- Remel, Inc.Nov 10, 2003
K031834 · XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
- Techlab, Inc.Nov 4, 2003
K033274 · GIARDIA II
- Ivd Research, Inc.Mar 5, 2003
K024113 · IVD CRYPTO/GIARDIA DFA
- Ivd Research, Inc.Sep 17, 2002
K020583 · IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96