ADVIA Chemistry XPT — Class II medical device recall Z-2704-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-09-07, distributed in AZ, CA, CO, IL, MA, MI, NY, TX…. Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test D
| Recall number | Z-2704-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2016-07-20 |
| Classified | 2016-08-30 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2018-06-07 |
| Distributed | AZ, CA, CO, IL, MA, MI, NY, TX, WA |
| Countries outside the US | AT, AU, BH, BR, CN, DE, DK, EG, ES, FI, FR, GB, GR, HU, IT, KR, MY, NL, NO, NZ, PT, SE, SG, SK, TR, VN |
| Reason classes | software |
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
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.