Z-0721-2021Class II

ADVIA Gamma-Glutamyl Transferase (GGT) Reagent -

Name: Z-0721-2021 ADVIA Gamma-Glutamyl Transferase (GGT) Reagent -
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2020-11-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-11-23 / Open, Classified / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in... on 2020-11-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0721-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-11-23
Posted: 2020-12-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
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)
Product code: JQA Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes
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.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Healthcare Diagnostics Urgent Field Safety Notice letter beginning November 23, 2020 via Fed Ex and outside the US the distribution is determined at the country level. Letter states reason for recall , health risk and action to take: For the product listed above, please perform the following steps: 1. Review and apply the preliminary precision performance characteristics of d8% CV at a GGT concentration of approximately 27 U/L 42 U/L provided. 2. Please review this letter with your Medical Director. 3. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 4. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Contact your Siemens Customer Care Center or your local Siemens technical support representative. The precision section of the IFUs will be updated when the investigation is complete. The updated IFUs will be uploaded into Document Library where all registered users who opt in to receive alerts will be notified of the updated IFU.
Quantity in commerce: 397 units US; 1713 units OUS
Distribution: 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. ¿¿¿¿ ¿¿¿¿¿
Product codes and lots: All lot codes. UDI: 10309495 (20 mL) = 00630414508344 10316298 (70 mL) = 00630414209753

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0721-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0721-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0722-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23

Product code JQA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)