Reported Oct 12, 2016 · Terminated

Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161

Siemens Healthcare Diagnostics Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 · 2 Edgewater Dr · Norwood, MA · 02062-4637

Is this the product you have?

  • Siemens RAPIDPoint 400 Measurement
  • Cartridge Siemens SMN numbers
    • 10329756
    • 10341161
Lot codes and dates
  • Serial Numbers2610900214
  • through 2621001325 Expiry Dates
    • Sept 13
    • 2016 through Dec. 6
    • 2016
Amount recalled
689 cartridges

This recall covers 2 products

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

Where it was sold

  • Nationwide

Why it was recalled

Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 7, 2017 · Data as of Sep 19, 6:00 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.