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

FDA device recall Z-2090-2008 · posted 2008-09-16 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions Diagnostics

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).

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.

Root cause

Other

Status

Terminated

Product code

LTJ

Quantity affected

64 kits

Distribution

Nationwide to: CA, FL, IL, IN, MD, MI ; Worldwide to: Bolivia, Chile, Egypt, Cyprus, Korea, Philippines, Taiwan, Uruguay

Date initiated

2008-05-21

Date posted

2008-09-16

Date terminated

2012-07-10

Location

Los Angeles, CA