| Date Initiated by Firm |
November 21, 2002 |
| Date Posted |
August 17, 2004 |
| Recall Status1 |
Terminated 3 on September 15, 2004 |
| Recall Number |
Z-1374-04 |
| Recall Event ID |
29679 |
| 510(K)Number |
K955157
|
| Product Classification |
Giardia Spp. - Product Code MHI
|
| Product |
ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496. |
| Code Information |
926230 |
Recalling Firm/
Manufacturer |
Remel, Inc.
12076 Santa Fe Trail Dr
(PO Box 14478, zip 66285-4478)
Lenexa KS 66215-3519
|
Manufacturer Reason
for Recall |
The conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause the dropper tips to become plugged. Quality control testing indicated that the reagents were still performing as intended, including the conjugates.
|
FDA Determined
Cause 2 |
Other |
| Action |
A potential contamination was noted in the conjugate in the ProSpecT Giardia/Cryptosporidium Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged. |
| Quantity in Commerce |
12 |
| Distribution |
US only |
| 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 and Original Applicant = ALEXON BIOMEDICAL, INC.
|
