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IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number...

FDA Device Recall #Z-0885-2017 — Class II — November 18, 2016

Recall Summary

Recall Number Z-0885-2017
Classification Class II — Moderate risk
Date Initiated November 18, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Healthcare Diagnostics, Inc.
Location Tarrytown, NY
Product Type Devices
Quantity 6697 kits (US: 1646 kits; OUS: 5081 kits)

Product Description

IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (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.

Reason for Recall

Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.

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.

Lot / Code Information

All lots L2KPS2/L2KPS6 - Lots 408, 409, 410 L2KPTS2/L2KPTS6 - Lots D112, D123, D124

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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