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

Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens… — recall Z-0204-2020

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

As described by U.S. FDA — Device Enforcement: Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0204-2020
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
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam
Barcode (EAN/GTIN)
00630414007960
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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