Siemens RAPIDPoint 405 Cartridges Recalled for Chloride Calibration Error
Siemens Healthcare Diagnostics is recalling RAPIDPoint 405 Measurement Cartridges due to an error in the value assignment for Chloride calibrators.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 6,638 units of the Siemens RAPIDPoint 405 Measurement Cartridge. The recall is due to an error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge.
The affected products have Siemens SMN numbers 10844812, 1028322, 10313971, and 10310469. The serial numbers range from 2610900214 through 2621001325, with expiry dates from September 13, 2016, through December 6, 2016.
The products were distributed nationwide and in foreign countries including Canada, the Bahamas, Germany, Japan, Mexico, Belgium, Italy, Spain, Korea, France, Austria, Poland, Australia, China, the United Arab Emirates, Bangladesh, Colombia, Czechoslovakia, and Bosnia. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 6,638
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Serial Numbers:2610900214 through 2621001325. Expiry Dates: Sept 13
- 2016 through Dec. 6
- 2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics Inc
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
Similar recalls
- HighSiemens RAPIDPoint 500 Lactate Cartridges Recalled for Electrolyte Error Codes
FDA (Devices) · 2014-07-30
- ModerateSiemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias
FDA (Devices) · 2015-09-30
- HighSiemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Sample Misidentification Risk
FDA (Devices) · 2013-11-06
- HighSiemens magnesium reagent cartridges recalled for false measurement results
FDA (Devices) · 2025-01-01
- HighSiemens RAPIDPoint 400 Blood Gas Analyzer Recalled for Sample Misidentification Risk
FDA (Devices) · 2013-11-06
- HighRAPIDPoint 500 Measurement Cartridges Recalled for Sodium Sensor Bias
FDA (Devices) · 2023-12-27