Recall Z-2090-2008 · LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Siemens Medical Solutions Diagnostics

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.

Date	Sep 16, 2008 (initiated May 21, 2008)
Status	Terminated
Reason	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).
Root cause	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 incl
Quantity	64 kits
Distribution	Nationwide to: CA, FL, IL, IN, MD, MI ; Worldwide to: Bolivia, Chile, Egypt, Cyprus, Korea, Philippines, Taiwan, Uruguay
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.