Reported Jul 25, 2018 · Terminated

Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586

Siemens Healthcare Diagnostics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466

Is this the product you have?

    • Dimension Vista¿ MULTI 2 SDIL
    • KD694
    • SMN# 10483586
Lot codes and dates
  • lot 7CDA79, UDI # (UDI) 008427680324177CDA7918090110483586, exp 2018-09-01; lot # 7DDA70, UDI # (UDI) 008427680324177DDA7018110110483586, exp 2018-11-01
Amount recalled
1195

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 12, 2020 · Data as of Sep 19, 6:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.