Thermo Fisher Scientific Recall 87309
Description: Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Thermo Fisher Scientific Recall 87309 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1202-2021 |
| Event ID | 87309 |
| Event Description | Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 |
| Product Type | Devices |
| Distribution | U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom |
| Quantity | 19 systems (1 system in U.S. and 10 system O.U.S.) |
| Recall 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. |
| Device Classification | 20210317 |
| Device Code Info | Model Number 99990000 GTIN: 06438153004925 Serial Numbers: CA100077, CA000055, CA100073, CA100074, CA000051, CA100062, CA100065, CA100069, CA100070 CA100063 CA000042, CA100071 CA100060, CA100059, CA000058, CA000053, CA000056, CA100061, CA100066 |
| Center Classification Date | 20210310 |
| Recall Initiation Date | 20210201 |
| Recalling Firm | Thermo Fisher Scientific |
| Initial Notification | Letter |
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