Z-1674-2021Class II

Centaur Syphilis Assay-SYP Kit, 200 Test -

Name: Z-1674-2021 Centaur Syphilis Assay-SYP Kit, 200 Test -
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2021-04-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-04-21 / Open, Classified / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in... on 2021-04-21. FDA classified it as Class II and gives the reason as "Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syphilis assay on the...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1674-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-21
Posted: 2021-05-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493
Product code: LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Reason for recall: Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syphilis assay on the ADVIA Centaur XP/XPT or ADVIA Centaur CP systems
Root cause tag: design
FDA root cause: Device Design
Action: Siemens issued Urgent Medical Device Correction (UMDC) to US affected customers via FedEx beginning on 04/21/2021. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 04/21/2021. Letter states reason for recall, health risk and Actions to be Taken by the Customer: Please review this letter with your Medical Director. If you have multiple ADVIA Centaur XP/XPT or ADVIA Centaur CP systems: Siemens recommends testing the ADVIA Centaur Syphilis assay on a separate system from the impacted ADVIA Centaur assays (ADVIA Centaur PRGE, T4 on the ADVIA Centaur XP/XPT and ADVIA Centaur AFP, COR, PHTN, VALP on the ADVIA Centaur CP) to avoid the potential carryover effect. If you have a single ADVIA Centaur XP/XPT or ADVIA Centaur CP system: It is important to prevent the impacted assays from being processed after the Syphilis assay without a Daily Cleaning Procedure (DCP) run in between. For example, this can be achieved by processing all Syphilis testing, running the DCP, and then proceeding with all other testing including the impacted assays. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product.
Quantity in commerce: 22550 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Burkina Faso, Croatia, Czech Republic, Egypt, Finland, France, Fren.Polynesia, Georgia, Germany, Germany, Greece, Guadeloupe, Italy, Kazakhstan, Latvia, Netherlands, Norway, Poland, Portugal, Qatar, Russian Fed., Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E., Ukraine, United Kingdom.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1674-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1674-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-02	2021-05-24

Product code LIP

K112343Class IITreponema Pallidum Treponemal Test Reagents; Quality Control MaterialsSiemens Healthcare Diagnostics, Inc. / cleared 2012-01-20

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)