Medical device recalls Moderate risk

Siemens Healthcare Diagnostics, Inc. recalls Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001

Recall date
August 15, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0204-2020
FDA classification
Class II
Brand / firm
Siemens Healthcare Diagnostics, Inc.
Sold / distributed
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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001

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