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

Recall Z-0863-2021 — Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion select

U.S. FDA — Device Enforcement · United States · 2020-12-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0863-2021
Date of alert: 2020-12-02
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): 11469032

Reported risk: Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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