Z-1202-2021Class II

Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

Name: Z-1202-2021 Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Creator: Thermo Fisher Scientific
Published: 2021-02-01
License: https://open.fda.gov/license/

Thermo Fisher Scientific Oy / initiated 2021-02-01 / Terminated / root cause: software

FDA source

Thermo Fisher Scientific began a recall of Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 on 2021-02-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1202-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-01
Posted: 2021-03-10
Terminated: 2024-01-10
Recalling firm: Thermo Fisher Scientific Oy
Product: Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Product code: DOP Mass Spectrometer, Clinical Use
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.
Root cause tag: software
FDA 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: [email protected] 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 in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1202-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1202-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-10

Product code DOP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)