Z-2704-2016Class II

ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3...

Name: Z-2704-2016 ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-07-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-07-20 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c... on 2016-07-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2704-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-20
Posted: 2016-08-30
Terminated: 2018-06-07
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
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: 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 tag: software
FDA 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 in commerce: 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.
Product codes and lots: CA1275002940294 and lower

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2704-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2704-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-30

Product code LCP

K110934Class IIAdvia Chemistry Hemoglobin A1c_3 (A1c_3) Automated Pretreatment AssaySiemens Healthcare Diagnostics / cleared 2011-08-25

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)