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

Recall Z-0205-2020 — Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000

U.S. FDA — Device Enforcement · United States · 2019-08-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0205-2020
Date of alert
2019-08-15
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)
00630414002026
Reported risk: Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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