Thermo Fisher Scientific: Medical Device Recall in 2021 - (Recall #: Z-1202-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

Product Classification:

Class II

Date Initiated: February 1, 2021

Date Posted: March 17, 2021

Recall Number: Z-1202-2021

Event ID: 87309

Reason for Recall:

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.

Status: Terminated

Product Quantity: 19 systems (1 system in U.S. and 10 system O.U.S.)

Code Information:

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

Distribution Pattern:

U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated