Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). The ADVIA Chemistry XPT System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour

Recall number

Z-2704-2016

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Product

ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). The ADVIA Chemistry XPT System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour

Status

Terminated

Initiated

2016-07-20

Posted

not on file

Terminated

2018-06-07

Reason

Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks (SMN: 11127343 and 11222123). This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). The ratio equation used to calculate ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results in IFCC units contains an error. The error results in falsely depressed HbA1cR results.

Root cause

Software design

Action

Siemens sent an Urgent Field Safety Notice dated July 20, 2016, to all affected customers via Fed Ex and the Urgent Field Safety Notice (CHSW16-02 July 2016) was e-mailed to regional countries for implementation Outside US (OUS). Customers have been advised to stop reporting results and call Siemens immediately to schedule service. The file with the typographical error is located on ADVIA Chemistry XPT Test Definition (TDef) disk. -- Field service personnel were sent a support bulletin describing the issue and instructing them how to correct the equation. Service engineers have been instructed to remove all version 1.0 TDef disks from customer sites regardless of whether they run the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment assay and report in IFCC units. Customers with questions were advised to contact their Siemens Customer Care Center or their local Siemens technical support representative.

Quantity

Domestic: 32 units; Foreign: 197 units

Distribution

Worldwide Distribution - US to MA, NY, MI, IL, TX, CO, AZ, CA, WA and Foreign distribution to the following countries: Australia, Austria, Bahrain, Brazil, China, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Malaysia, Netherlands, New Zealand, Norway, Portugal, Portugal, Republic Korea, Singapore, Slovakia, Spain, Sweden, Turkey, United Kingdom, and Vietnam.

Lot, serial or model codes

CA1275002940294 and lower

510(k) numbers

["K110934"]

PMA numbers

not on file

Product code

LCP

Firm FEI

2432235

Firm city

Tarrytown

Firm state

NY

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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