FDAClass IIIOctober 12, 2016

Siemens RAPIDPoint 400 Measurement Cartridge Siemens recall

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

Why was Siemens RAPIDPoint 400 Measurement Cartridge Siemens recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
Recalling firm
Siemens Healthcare Diagnostics Inc
Quantity
689 cartridges
Distribution
Nationwide: Foreign: Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia
Recall date
October 12, 2016
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls