| 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. |
| FEI Number |
1000520007
|
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 |
|---|
|
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.
|
| 510(K) Database | 510(K)s with Product Code = MHI
|
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