Recall Z-1202-2021 ยท DOP Mass Spectrometer, Clinical Use
Thermo Fisher Scientific
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
| Date | Feb 1, 2021 |
| Status | Terminated |
| Reason | Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in sample chromatogram. The resulting sample would show a Vitamin D-concentration that is an unusual situation for human serum and plasma samples and would indicate a severe Vitamin D deficiency. |
| Root cause | Software design |
| Action | On 02/01/2021, the firm sent an "URGENT - MEDICAL DEVICE RECALL" Notification Letter to inform customers that the Recalling Firm has identified that there is a software anomaly in the Analyzer Software subcomponent called Suhaili Service (version 2.0.3 and earlier) that is affecting the Analyzer. Suhaili Service controls raw data processing based on assay configuration data from Sample Prep software. Processed results are sent to Sample Prep software for patient result reporting. This anomaly, as a result of this interface, has a potential risk of reporting wrong patient results for Vitamin D. |
| Quantity | 19 systems (1 system in U.S. and 10 system O.U.S.) |
| Distribution | U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.