—#151295

Product

IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.

FDA product code: MTF — Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P930027
Affected lot / code info: All lots LKPS1/LKPS5 - Lots 443, 445, 446 LKPTS1 - Lot D116

Why it was recalled

Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm, Siemens, sent an "Urgent Medical Device Correction Letter" (IMC 17-07.A.US, dated 11/2016) was sent via FedEx on 11/18/2016 to the US customers and an "Urgent Field Safety Notice" dated 11/2016 to customers outside the US (distribution is determined at the country level). The letter/notice described the product, problem and actions to be taken. Additionally, Field service personnel were sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers were instructed to review letter with your medical doctor; review products and follow instructions; complete and return the attached Field Correction Effectiveness Check Form within 30 days by fax to Customer Care Center at (312) 275-7795; retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: Worldwide Distribution-US (nationwide)and the following countries: Afghanistan, Albania, Algeria, Argentina, Aruba, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg, Brazil, British Guyana, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Rep., Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Great Britain, Grenada, Guatemala, Honduras, Hungary, Iceland, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kosovo, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Spain, South Africa, South Korea, Suriname, Switzerland, Syria, Taiwan, Tadjikistan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, and Vietnam.

Timeline

Recall initiated: 2016-11-18
Terminated: 2018-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151295. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.