Recall Z-1961-2015 ยท CGA Glucose Oxidase, Glucose
Siemens Healthcare Diagnostics, Inc
The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
| Date | Jul 2, 2015 (initiated May 6, 2015) |
| Status | Terminated |
| Reason | D50 and D51 Diagnostic error codes are not functional. |
| Root cause | Software design |
| Action | Siemens sent an Urgent Field Safety Notice April 2015, to all affected customers. Customers were notified of the recall beginning on May 6, 2015 via Federal Express. Foreign customers were notified starting on May 5, 2015 via method determined by each countries local regulations and procedures. The notification informs customers of the issue and asks customers to do the following: Ensure that the Glucose and Lactate sensor contacts are aligned and completely seated with the contacts on the analyzer, Analyze a minimum of 2 levels of quality control material after installing the sensors, as |
| Quantity | 122 devices |
| Distribution | Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Bosnia, Herzog,Brazil, Brunei, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany,Georgia, Greece, Hong Kong, Iceland, India, Indone |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031560 | BAYER RAPIDLAB 1200 SYSTEM Bayer Healthcare, LLC, Dec 17, 2003 |