Recalls / —
—#147912
Product
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, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
- FDA product code
- KHP — Acid, Lactic, Enzymatic Method
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K113216
- Affected lot / code info
- Software Version 2.2A
Why it was recalled
Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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 days. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens Technical Support representative. For questions regarding this recall call 781-269-3000.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics Inc
- Address
- 2 Edgewater Dr, Norwood, Massachusetts 02062-4637
Distribution
- Distribution pattern
- Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
Timeline
- Recall initiated
- 2016-07-05
- Posted by FDA
- 2016-08-19
- Terminated
- 2017-08-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #147912. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.