COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is… recallZ-2090-2008 · Siemens Medical Solutions Diagnostics · initiated May 21, 2008
Terminated All recalls posted in September 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-2090-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 21, 2008
- Posted by the FDA
- Sep 16, 2008
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Quantity
- 64 kits
- Product code
- LTJ
- FDA submissions
- P930027
- Distribution
- Nationwide to: CA, FL, IL, IN, MD, MI ; Worldwide to: Bolivia, Chile, Egypt, Cyprus, Korea, Philippines, Taiwan, Uruguay
Product description
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 (models, lots, serial numbers)
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
Other devices under the same FDA submission
2 devices cleared under P930027 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- IMMULITE® 2000 Systems PTS PSA 10706281Siemens Healthcare Diagnostics Products Ltd · Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer1 recall1 report
- IMMULITE® 2000 Systems PTS PSA 10706282Siemens Healthcare Diagnostics Products Ltd · Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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