Atellica Gamma-Glutamyl Transferase — Class II medical device recall Z-0722-2021
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2020-12-30, distributed nationwide. Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coeffici
| Recall number | Z-0722-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2020-11-23 |
| Classified | 2020-12-23 |
| Reported by FDA | 2020-12-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HR, IE, IL, IN, IR, IT, JP, KE, KR, KW, LT, LV, MX, MY, NL, NO, NZ, OM, PH, PK, PL, PT, QA, RO, SA, SE, SG, SK, TH, TR, TW, UY, VN, ZA |
| UPC / GTIN / UDI-DI | 00630414596440 |
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
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.