The Recall Desk
HighFDA (Devices)·Z-2028-2021·Announced 2021-07-14

Atellica analyzer valves recalled for manufacturing defect affecting diagnostic accuracy

Siemens recalls Atellica analyzers (CH 930, IM 1300, IM 1600) due to valve manufacturing defects that may cause leaking and affect clinical test result accuracy.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with potential for inaccurate clinical test results due to valve leakage in high-pressure applications. Classified as High under the rubric for risk-of-harm products where no injury has been reported.

Plain-English summary

Siemens Healthcare Diagnostics is recalling valves used in Atellica CH 930, Atellica IM 1300, and Atellica IM 1600 analyzers due to a manufacturing defect. The affected valves may wear and leak over time, particularly in high-pressure or high-wear applications. When valves leak, the system may produce inaccurate results for clinical tests.

For the Atellica IM 1600 specifically, the recall affects 123 units distributed nationwide in the United States and 751 units distributed internationally. Affected serial number ranges include IH00876 through IH01451 and IRH00258xxxx through IRH01169xxxx (where 'xxxx' represents any number).

Laboratory operators using the affected analyzers should contact Siemens Healthcare Diagnostics for guidance on valve inspection and replacement.

The recalled product

Product
Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Diagnostic Analyzer
Hazard
  • manufacturing-defect
  • valve-leakage
  • result-inaccuracy

Distribution

Distributed nationwide across the United States.

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