FDA Medical Device Recalls (openFDA)
Genzyme Diagnostics: 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
- Recall number
- Z-0770-04
- Recalling firm
- Genzyme Diagnostics
- 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
- Status
- Terminated
- Initiated
- 2004-02-23
- Posted
- 2004-07-20
- Terminated
- 2004-09-15
- Reason
- False Positive results.
- 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
- 2671 kits
- Distribution
- Product was manufactured for two firms who subdistributed it, Meridian Bioscience of Cincinnati OH and Becton Dickenson, Sparks MD.
- Lot, serial or model codes
- Lots 081077, 081093, 081138, 071093, 071138.
- 510(k) numbers
- ["K983399"]
- PMA numbers
- not on file
- Product code
- MHI
- Firm FEI
- 1000520007
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28