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U.S. Department of Health and Human Services

Class 2 Device Recall COATACOUNT PSA IRMA kit

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  Class 2 Device Recall COATACOUNT PSA IRMA kit see related information
Date Initiated by Firm May 21, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on July 10, 2012
Recall Number Z-2090-2008
Recall Event ID 48436
PMA Number P930027 
Product Classification prostate-specific antigen (psa) for management of prostate cancers - Product Code LTJ
Product COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in monitoring patients for disease progress or response to therapy.
Code Information LOT NUMBERS: IKPS1 884 - 100 test size, exp. 5/30/2008; IKPS2 864 - 200 test size, exp. 5/30/2008; IKPS5 862 - 500 test size, exp. 5/30/2008; IKPSX 854 - 1000 test size, exp. 5/30/2008 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions Diagnostics
5700 W 96th St
Los Angeles CA 90045-5544
For Additional Information Contact Pushpinder Marshall
310-645-8200 Ext. 7417
Manufacturer Reason
for Recall		 The field action was initiated after the firm confirmed that the Coat-A-Count PSA IRMA kit (IKPS1, 2, 5, X) exhibits a low bias, which is evident when comparing results with other methods, including the IMMULITE PSA kits. Coat-A-Count PSA IRMA results are, for example, approximately 20% lower when compared to results obtained with the IMMULITE 2000 Third Generation PSA assay (L2KUP).
FDA Determined
Cause 2		 Other
Action A Customer Bulletin (Urgent Field Safety Notice) was prepared and sent by fax or mail to all affected Siemens Healthcare Diagnostics Branches on May 21, 2008 both in the United States and elsewhere for communication with the affected customers. This bulletin advises the customer of the problem and the discontinuation of the product. Customers were also instructed to forward this notification to anyone to whom you may have distributed this product and if they have additional questions, please contact your local technical service center @ 1-877-229-3711. A Confirmation (Fax-back) Form is included to ensure that all customers have been notified. The goal is to complete 100% effectiveness by July 31, 2008. If you have questions, contact Siemens Technical Solutions at 1-877-229-3711, option 11, option 6.
Quantity in Commerce 64 kits
Distribution Nationwide to: CA, FL, IL, IN, MD, MI ; Worldwide to: Bolivia, Chile, Egypt, Cyprus, Korea, Philippines, Taiwan, Uruguay
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.
PMA Database PMAs with Product Code = LTJ and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS INC.
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