Date Initiated by Firm | February 23, 2004 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on September 15, 2004 |
Recall Number | Z-0770-04 |
Recall Event ID |
28473 |
510(K)Number | K983399 |
Product Classification |
Giardia Spp. - Product Code MHI
|
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 |
Code Information |
Lots 081077, 081093, 081138, 071093, 071138. |
Recalling Firm/ Manufacturer |
Genzyme Diagnostics 6659 Top Gun St San Diego CA 92121-4113
|
For Additional Information Contact | Gene Goorchenko 858-777-2614 |
Manufacturer Reason for Recall | False Positive results. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MHI
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