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Terminated

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

FDA Recall Z-0770-04 · Posted 2004-07-20

Recalling FirmGenzyme Diagnostics
Recall StatusTerminated
Product CodeMHI
Date Initiated2004-02-23
Date Terminated2004-09-15
Product Quantity2671 kits

Reason for Recall

False Positive results.

Firm Action

Recall was by letters sent in March 2004 requesting distributors subrecall to customers and have them discard/destroy the lots in question.

Root Cause

Other

Distribution Pattern

Product was manufactured for two firms who subdistributed it, Meridian Bioscience of Cincinnati OH and Becton Dickenson, Sparks MD.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983399GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYGenzyme Diagnostics · 1999-01-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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