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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 23, 2005
Date PostedMarch 08, 2005
Recall Status1 Terminated 3 on September 02, 2005
Recall NumberZ-0576-05
Recall Event ID 31253
510(K)NumberK925802 
Product Classification Enzyme Immunoassay, Digoxin - Product Code KXT
ProductAccess Immunoasay Systems Digoxin Reagent
Code Information Lots 323171; 416110; 417703; 419534
Recalling Firm/
Manufacturer
Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactKathleen Jaker
714-961-4123
Manufacturer Reason
for Recall
Variability in results on Patient and QC results of 20-25%, high and low.
FDA Determined
Cause 2
Other
ActionLetters were sent to customers via UPS overnite, they request that alternative methods be used for patient testing until new material is made available. Customers are requested to ask for replacements using a fax back form.
Quantity in Commerce4352 domestically.
DistributionNationwide and Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KXT
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