Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500
FDA device recall Z-2816-2015 · posted 2015-09-24 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Reason for recall
- RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
- Action taken
- Siemens Healthcare sent an Urgent Field Safety Notice letter dated August 2015 to all affected customers. The notice identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Field Correction Effectiveness Check Form attached. For questions contact your Siemens Customer Care Center or ther local Siemens technical support representative.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KHP
- Quantity affected
- 49 cartridges
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Canada, Albania, Austria, Australia, Bosnia Herzeg., Bangladesh, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germa
- Date initiated
- 2015-08-24
- Date posted
- 2015-09-24
- Date terminated
- 2016-05-23
- Location
- Norwood, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RAPIDPOINT 500 BLOOD GAS ANALYER (K113216) | Siemens Healthcare Diagnostics | 2012-05-03 |