ADVIA Chemistry XPT recall: Software Issue
ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when…
Why was ADVIA Chemistry XPT recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
CA1275002940294 and lower
- Product
- ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Recall date
- September 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)