Siemens Atellica GGT Reagent Recalled for Low-End Repeatability Imprecision
Siemens Healthcare Diagnostics is recalling Atellica GGT Reagent because it may show repeatability imprecision outside performance data on some analyzers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential diagnostic inaccuracy without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica Gamma-Glutamyl Transferase (GGT) Reagent (Siemens Material Number 11097597). The product is used for in vitro diagnostic testing to quantitatively determine gamma-glutamyl transferase in human serum and plasma.
The recall is due to low-end repeatability imprecision. The 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. This issue may affect the accuracy of test results.
The recall includes 731 units in the US and 16,824 units outside the US. The product was distributed worldwide, including in the United States, Australia, Canada, and numerous other countries. All lot codes are affected. Users should contact Siemens Healthcare Diagnostics for further instructions regarding the recall.
The recalled product
- Product
- Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes. UDI: 00630414596440
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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