Siemens Healthcare recalls GGT reagents for lab testing due to potential low repeatability. Affected reagents may show inconsistent results on some analyzers. Contact for replacement or return.
Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.
Siemens Healthcare is recalling GGT reagents used in lab testing because they may produce inconsistent results on some analyzers. This could lead to inaccurate test results if the reagent is used without proper calibration.
The reagent may show inconsistent results (high coefficient of variation) on some analyzers, meaning test results could vary more than expected. This could lead to inaccurate blood test results if not properly calibrated.
Lab technicians and healthcare providers who use Siemens GGT reagents for blood tests. Those using the reagents without proper calibration are at slightly higher risk of inaccurate test results.
Check for Siemens Material Numbers (SMN): 1030949: 20mL (lot 00630414508344) or 70mL (lot 00630414209753). The reagent is sold for in vitro diagnostic use in blood tests.
Look for the lot number on the reagent container to confirm if it's affected.
The reagent may show inconsistent results (high coefficient of variation) on some analyzers, which could lead to inaccurate blood test results.
The recall does not specify a remedy, so contact Siemens Healthcare directly for guidance.
The reagent is safe for use but may produce inconsistent results on some analyzers, so proper calibration is needed.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0721-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0721-2021 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
