CLASS II ONGOING Device recall · Reported 30 Dec 2020 · FDA Enforcement Report

Advia Gamma-Glutamyl Transferase (GGT) Reagent recalled

Siemens Healthcare Diagnostics is recalling Advia Gamma-Glutamyl Transferase (GGT) Reagent, distributed nationwide in the US. The recall was initiated on 23 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot codes. UDI: 10309495 (20 mL) = 00630414508344 10316298 (70 mL) = 00630414209753

Quantity recalled397 units US; 1713 units OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0721-2021
FDA event ID: 86900
Recalling firm: Siemens Healthcare Diagnostics, Tarrytown, NY
Classification: Class II
Status: Ongoing
Recall initiated: 23 Nov 2020
FDA classified: 23 Dec 2020
Reported: 30 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

23 Nov 2020	Recall initiated by company
23 Dec 2020	Classified by FDA	+30 days
30 Dec 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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)

Where it was distributed

Worldwide distribution - US Nationwide distribution and the countries of Australia, Austria, Bahamas, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Uruguay, Vatican City, Vietnam. ¿¿¿¿ ¿¿¿¿¿

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All lot codes. UDI: 10309495 (20 mL) = 00630414508344 10316298 (70 mL) = 00630414209753

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 86900

This product is part of a recall event; the main page for the event is Atellica Gamma-Glutamyl Transferase (GGT) Reagent recalled.

Reported	Class	Recall	Company	Reason	Where
30 Dec 2020	CLASS II	Atellica Gamma-Glutamyl Transferase (GGT) Reagent recalled	Siemens Healthcare Diagnostics	Other	Nationwide

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