Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1797-2020 — Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower

U.S. FDA — Device Enforcement · United States · 2020-02-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1797-2020
Date of alert
2020-02-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00630414002163
Reported risk: Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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