Siemens ADVIA GGT Reagent Recalled for Low-End Repeatability Imprecision
Siemens Healthcare Diagnostics is recalling ADVIA Gamma-Glutamyl Transferase (GGT) Reagent because it may show repeatability imprecision outside of listed performance data.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential diagnostic inaccuracy (imprecision) which poses a risk of harm through incorrect medical decisions, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Gamma-Glutamyl Transferase (GGT) Reagent. The product is used for in vitro diagnostic testing to measure gamma-glutamyl transferase in human serum and plasma. The recall involves 397 units in the US and 1,713 units outside the US, with worldwide distribution across numerous countries.
The recall was initiated because the reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use on some analyzers. This issue is classified as a Class II recall by the FDA.
The affected product includes Siemens Material Numbers 10309495 (20 mL) and 10316298 (70 mL). All lot codes are affected. Healthcare facilities and laboratories should stop using the product and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- ADVIA 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): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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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