—#152223

Product

IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 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: Lot Numbers: 1) D01196 - Expiration date 2016-12-31 2) D0120 - Expiration date 2017-03-31

Why it was recalled

Negative bias results with the IMMULITE /IMMULITE 1000 Third Generation PSA (prostate-specific antigen) kit was confirmed for two lots (D0119 and D0120). The investigation by Siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/mL.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Siemens issued an Urgent Medical Device Recall Notice letter dated December 21, 2016, to their U.S.A customers via Fed Ex and an Urgent Field Safety Notice letter dated December 2016, to customers outside the US (OUS). The notices instruct customers to discontinue use of and discard the affected kit lots listed in Table 1 of the customer communication. Customers are requested to review the UMDR and or the UFSN with their Medical Director. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days. U.S.A customers are advised to fax the Effectiveness Check questionnaire to (312) 275-7795. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers with questions should contact their 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 countries of Denmark, Brazil, Croatia and Germany

Timeline

Recall initiated: 2016-12-21
Terminated: 2018-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152223. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.