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Thermo Fisher Scientific Recall 87309

Description: Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

Thermo Fisher Scientific Recall 87309 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1202-2021
Event ID87309
Event DescriptionCascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Product TypeDevices
DistributionU.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom
Quantity19 systems (1 system in U.S. and 10 system O.U.S.)
Recall ReasonDue 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 Classification20210317
Device Code InfoModel 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 Date20210310
Recall Initiation Date20210201
Recalling FirmThermo Fisher Scientific
Initial Notification Letter
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