Reported Dec 30, 2020 · Ongoing
ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- ADVIA Gamma-Glutamyl Transferase (GGT)
- Reagent - Product UsageFor in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma
- Siemens Material Number (SMN)ADVIA
- Chemistry10309495 (20 mL) 10316298 (70 mL)
- Lot codes and dates
- All lot codes
- UDI10309495 (20 mL) = 00630414508344 10316298 (70 mL) = 00630414209753
- Amount recalled
- 397 units US; 1713 units OUS
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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