Siemens Healthcare Diagnostics, Inc: 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

Recall number

Z-1674-2021

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

Status

Open, Classified

Initiated

2021-04-21

Posted

not on file

Terminated

not on file

Reason

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

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

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.

Lot, serial or model codes

All Lots

510(k) numbers

["K112343"]

PMA numbers

not on file

Product code

LIP

Firm FEI

1219913

Firm city

East Walpole

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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