Date Initiated by Firm |
December 03, 2003 |
Date Posted |
January 06, 2004 |
Recall Status1 |
Terminated 3 on April 20, 2005 |
Recall Number |
Z-0295-04 |
Recall Event ID |
27874 |
510(K)Number |
K001009
|
Product Classification |
C-Reactive Protein, Antigen, Antiserum, And Control - Product Code DCK
|
Product |
POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only.
COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum.
|
Code Information |
Lot numbers CP4274-0769M (EXP. 09/04) and CP4335-0812M (EXP. 11/04) |
Recalling Firm/ Manufacturer |
Polymedco, Inc 510 Furnace Dock Road Cortlandt Manor NY 10567-6220
|
For Additional Information Contact |
Ms. Helen Landicho 914-739-5400
|
Manufacturer Reason for Recall |
Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications.
|
FDA Determined Cause 2 |
Other |
Action |
By phone on 12/3/03 and by mail on 12/5/03. |
Quantity in Commerce |
165 Kits |
Distribution |
Medical facilities, physicians, diagnostic laboratories, and distributors located nationwide. |
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 = DCK and Original Applicant = RANDOX LABORATORIES, LTD.
|