Thermo Fisher Scientific: Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

Recall number

Z-1202-2021

Recalling firm

Thermo Fisher Scientific

Product

Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

Status

Terminated

Initiated

2021-02-01

Posted

not on file

Terminated

2024-01-10

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. Customers are informed, As an immediate correction the following instructions must be followed with Cascadion SM Clinical Analyzer Software versions 2.0.2 and earlier until the installation of the new software version 2.1. 1. Please distribute this information immediately to any staff that may be impacted by this issue. 2. Please change the Quick Connect Cartridge Cs on the instrument to new ones. 3. After the cartridge change, if a sample is reported to have concentration of total 25-hydroxy Vitamin D below assay measuring range, follow these instructions to prevent the error from being reported: a. Repeat the sample analysis with a Cascadion SM Clinical Analyzer b. In case the repeated result is below assay measuring range, the sample should be rerun on another assay and platform. 4. Retain a copy of this letter for your laboratory records. 5. As appropriate, contact your Medical Professional for evaluation of further action. 6. Please, fill out the MEDICAL DEVICE RECALL- Response Form and return it within 5 days of the date of this letter to your manufacturer as instructed in the form and as listed: Email: vigilance.clinical.fi@thermofisher.com The actions to be taken by the Recalling Firm: 1. The Recalling Firm has informed the appropriate Regulatory Agencies. 2. When, available, the final corrective action will be to update Clinical Analyzer software v2.1

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

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

DOP

Firm FEI

3007262384

Firm city

Vantaa

Firm state

not on file

Firm country

Finland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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