Z-0885-2017Class II

IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2...

Name: Z-0885-2017 IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-11-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-11-18 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN... on 2016-11-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0885-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-18
Posted: 2016-12-22
Terminated: 2018-06-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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.
Product code: MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 6697 kits (US: 1646 kits; OUS: 5081 kits)
Distribution: 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.
Product codes and lots: All lots L2KPS2/L2KPS6 - Lots 408, 409, 410 L2KPTS2/L2KPTS6 - Lots D112, D123, D124

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0885-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0884-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22
Z-0885-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22

Product code MTF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)