CLASS III Device recall · Reported 12 Oct 2016 · FDA Enforcement Report

Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN recalled

Siemens Healthcare Diagnostics is recalling Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, distributed nationwide in the US. The recall was initiated on 2 Sep 2016 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesSerial Numbers:2610900214 through 2621001325. Expiry Dates: Sept 13, 2016 through Dec. 6, 2016

Quantity recalled6638 cartridges

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2913-2016
FDA event ID: 75108
Recalling firm: Siemens Healthcare Diagnostics, Norwood, MA
Classification: Class III
Status: Terminated
Recall initiated: 2 Sep 2016
FDA classified: 30 Sep 2016
Reported: 12 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Sep 2016	Recall initiated by company
30 Sep 2016	Classified by FDA	+28 days
12 Oct 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469

Where it was distributed

Nationwide: Foreign: Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Serial Numbers:2610900214 through 2621001325. Expiry Dates: Sept 13, 2016 through Dec. 6, 2016

Where was it sold?

Nationwide: Foreign: Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 75108

This product is part of a recall event; the main page for the event is Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN recalled.

Reported	Class	Recall	Company	Reason	Where
12 Oct 2016	CLASS III	Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN recalled	Siemens Healthcare Diagnostics	Other	Nationwide

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