Siemens RAPIDPoint 400 Cartridges Recalled for Chloride Calibration Error
Siemens is recalling RAPIDPoint 400 Measurement Cartridges because of 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 agency classification is Class III, which the rubric defines as typically unlikely to cause adverse health consequences.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 689 units of the RAPIDPoint 400 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 are identified by Siemens SMN numbers 10329756 and 10341161. The serial numbers range from 2610900214 through 2621001325, and the expiry dates range 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 recalled product
- Product
- Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 689
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.
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