Z-1119-2017Class II

IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog)

Name: Z-1119-2017 IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog)
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-12-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-12-21 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with... on 2016-12-21. FDA classified it as Class II and gives the reason as "Negative bias with IMMULITE /IMMULITE 1000 Third Generation PSA (prostate-specific antigen) kit. The investigation by Siemens has confirmed that patient samples exhibit an average negative bias of approximately -22%...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1119-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-21
Posted: 2017-01-31
Terminated: 2018-06-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS 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.
Product code: MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Reason for recall: Negative bias with IMMULITE /IMMULITE 1000 Third Generation PSA (prostate-specific antigen) kit. 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 tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 1379 kits (190 kits in U.S.A and 1189 Kits internationally) in total
Distribution: Worldwide Distribution - US Nationwide and the countries of Denmark, Brazil, Croatia and Germany
Product codes and lots: Lot Numbers: 1) 0336 - Expiration date 2017-01-31 2) 0337 - Expiration date 2017-02-28 3) 0338 - Expiration date 2017-05-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1119-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1119-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-01-31
Z-1120-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-01-31

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)