Recall Z-1586-2016 ยท DOP Mass Spectrometer, Clinical Use
Ab Sciex
Analyst MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP 4500MD LC/MS/MS System, Instrument Part Number: 5031231 3200MD series and 4500MD series are mass spectrometers inte
| Date | Apr 29, 2016 (initiated Feb 24, 2016) |
| Status | Terminated |
| Reason | Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis. |
| Root cause | Software design |
| Action | Sciex sent an Urgent Medical Device Correction letter dated February 29, 2016, to all affected US customers via Fedex on March 2, 2016. International customers were notified beginning on March 3, 2016. The letter informed customers of the issue and requests that they take temporary steps to eliminate the potential for erroneous events. In addition, a software update is in development and is expected to be available in approximately 4 weeks. Customers with questions were instructed to contact SCIEX at 1-289-982-2531. |
| Quantity | 279 |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to the following countries: AUSTRIA CANADA CHINA FRANCE GERMANY INDIA IRELAND ITALY KOREA MALAYSIA NETHERLANDS NORWAY RUSSIA SINGAPORE SPAIN SWITZERLAND UNITED KINGDOM |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.