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.
This recall has been terminated (originally issued September 16, 2008).
- Recall Initiated
- May 21, 2008
- Posted
- September 16, 2008
- Terminated
- July 10, 2012
- Recall Number
- Z-2090-2008
- Quantity
- 64 kits
- Firm Location
- Los Angeles, CA
- Official Source
- View on FDA website ↗
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).
Distribution
Nationwide to: CA, FL, IL, IN, MD, MI ; Worldwide to: Bolivia, Chile, Egypt, Cyprus, Korea, Philippines, Taiwan, Uruguay
Lot / Code Info
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
Root Cause
Other
Action Taken
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.