Z-0770-04

Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two names as follows...

Name: Z-0770-04 Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two names as follows...
Creator: Genzyme Diagnostics
Published: 2004-02-23
License: https://open.fda.gov/license/

Sekisui Diagnostics, LLC / initiated 2004-02-23 / Terminated

FDA source

Genzyme Diagnostics began a recall of Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two names as follows: Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid... on 2004-02-23. The reason FDA records is "False Positive results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0770-04
Status: Terminated
Initiated: 2004-02-23
Posted: 2004-07-20
Terminated: 2004-09-15
Recalling firm: Sekisui Diagnostics, LLC
Product: Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two names as follows: Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac Giardia/Crypotsporidium Rapid Assay
Product code: MHI Giardia Spp.
Reason for recall: False Positive results.
FDA root cause: Other
Action: Recall was by letters sent in March 2004 requesting distributors subrecall to customers and have them discard/destroy the lots in question.
Quantity in commerce: 2671 kits
Distribution: Product was manufactured for two firms who subdistributed it, Meridian Bioscience of Cincinnati OH and Becton Dickenson, Sparks MD.
Product codes and lots: Lots 081077, 081093, 081138, 071093, 071138.

Product code MHI

K983399Class IIGiardia/cryptosporidium Combo Rapid AssayGenzyme Diagnostics / cleared 1999-01-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)