Date Initiated by Firm |
April 03, 2006 |
Date Posted |
May 19, 2006 |
Recall Status1 |
Terminated 3 on August 07, 2006 |
Recall Number |
Z-0875-06 |
Recall Event ID |
35112 |
510(K)Number |
K984067
|
Product Classification |
Fluorometric Method, Cpk Or Isoenzymes - Product Code JHX
|
Product |
Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic. |
Code Information |
Lot #245276002; 245289002; 245304002; 245318002; 245332002; 245361002; 246023002; 246037002; 246051002; 246065002; and 246079002 |
Recalling Firm/ Manufacturer |
Dade Behring , Inc. 500 GBC Dr., Mailstop 514 PO BOX 6101 Newark DE 19714-6101
|
For Additional Information Contact |
Fran Dillon 302-631-6951
|
Manufacturer Reason for Recall |
Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.
|
FDA Determined Cause 2 |
Other |
Action |
Customers were provided clear written instructions (04/06/2006) to discontinue use and discard remaining inventory of products over 2 months old. In addition, each customer is being contacted by phone as an effectiveness verification. Recalling firm is also instructing Stratus CS customers to process all samples and dilutions in duplicate. |
Quantity in Commerce |
3229 cartons of 100 TestPaks |
Distribution |
Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia. |
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.
|
510(K) Database |
510(K)s with Product Code = JHX and Original Applicant = DADE BEHRING, INC.
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