Recall Z-2601-2016 ยท KHP Acid, Lactic, Enzymatic Method
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02,
| Date | Aug 19, 2016 (initiated Jul 5, 2016) |
| Status | Terminated |
| Reason | Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States |
| Root cause | Under Investigation by firm |
| Action | Siemens sent a Customer Notification dated July 2016 to all affected domestic (US) customers via Federal Express on July 5, 2016. Customers were asked to take the following actions: Please do not use the dialysate mode. If you have enabled this feature, please disable it by following these instructions: 1. At the System screen, select Setup. 2. Select Secured Options > Analysis Options. 3. Unselect Dialysate. 4. Select the Continue button 3 times. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check attached to this letter within 7 |
| Quantity | 76 |
| Distribution | Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113216 | RAPIDPOINT 500 BLOOD GAS ANALYER Siemens Healthcare Diagnostics, May 3, 2012 |