Z-2090-2008

COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in monitoring patients for...

Name: Z-2090-2008 COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in monitoring patients for...
Creator: Siemens Medical Solutions Diagnostics
Published: 2008-05-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-05-21 / Terminated

FDA source

Siemens Medical Solutions Diagnostics began a recall of 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 on 2008-05-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2090-2008
Status: Terminated
Initiated: 2008-05-21
Posted: 2008-09-16
Terminated: 2012-07-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
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 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 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
Product codes and lots: 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

Product code LTJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)