Drug recall
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The…
FDA recall event 72044 · Class II · Siemens Healthcare Diagnostics Inc
Key facts
| Event ID | 72044 |
|---|---|
| Recall numbers | Z-2813-2015, Z-2814-2015, Z-2815-2015, Z-2816-2015 |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Product type | Devices |
| Products | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory…, Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory…, Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory…, Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results |
| Initiation date | Aug 24, 2015 |
| Report date | Sep 30, 2015 |
| Termination date | May 23, 2016 |
| City | Norwood |
| State | MA |
| Country | United States |
| FEI number | 3002637618 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: