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.
What this means for you
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.
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