Siemens Healthcare recalls Atel:lica GGT reagents due to potential low repeatability in lab tests. Affected lots may show inconsistent results on some analyzers. No remedy specified in recall notice.
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 its Atellica Gamma-Glutamyl Transferase (GGT) reagents because they may show inconsistent results on some lab analyzers. This could lead to inaccurate test results if used without proper calibration.
The reagents may show inconsistent results (high coefficient of variation) on some lab analyzers, potentially leading to inaccurate test results. This could affect diagnosis if the test is critical for patient care.
Lab technicians and healthcare providers who use these reagents for blood tests. Those using the reagents with analyzers that require high precision are most at risk.
Check for Siemens Material Number (SMN) 11097597 on the reagent packaging. All lot codes are affected. The Unique Device Identifier (UDI) is 00630414596440.
Look for Siemens Material Number (SMN) 11097597 and the Unique Device Identifier (UDI) 00630414596440 on the reagent packaging.
The recall does not state that the reagent is unsafe; it may show inconsistent results on some analyzers, but no specific safety risks are mentioned.
The recall notice does not specify a remedy, so no action is required beyond checking the packaging for the affected identifiers.
The recall does not specify which analyzers are affected; it only mentions that the reagents may show inconsistent results on some analyzers.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0722-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0722-2021 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.
