Siemens RAPIDPoint 400 Measurement Cartridge recallZ-2912-2016 · Siemens Healthcare Diagnostics Inc · initiated Sep 2, 2016
Class III Terminated All recalls posted in September 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
FDA root cause category: Under Investigation by firm
What the company is doing
Siemens Healthcare issued An Urgent Field Safety Notice via e-mail to affected Siemens Healthcare Diagnostics Regional offices on September 2, 2016 both in the United States and outside of the United States, for communication with affected customers e: the bias of the chloride values. US accounts sent hard copy via Federal Express and requested to: Complete and return the Field Correction Effectiveness Check form attached to this letter within 7 days. Review this letter with your Medical Director. Questions:Contact your Siemens Customer Care Center or your local Siemens technical support representative.
Recall details
- Recall number
- Z-2912-2016
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Sep 2, 2016
- Posted by the FDA
- Sep 30, 2016
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 689 cartridges
- Product code
- JFS
- FDA submissions
- K002738
- Distribution
- Nationwide: Foreign: Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia
Product description
Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
Code information (models, lots, serial numbers)
Serial Numbers:2610900214 through 2621001325 Expiry Dates: Sept 13, 2016 through Dec. 6, 2016
Other devices under the same FDA submission
1 device cleared under K002738 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- RAPIDPoint® 400/405/500 Wash/Waste Cartridge 10329097Siemens Healthcare Diagnostics Inc. · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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