CLASS II Device recall · Reported 17 Mar 2021 · FDA Enforcement Report
Cascadion SM Clinical Analyzer recalled by Thermo Fisher Scientific
Thermo Fisher Scientific is recalling Cascadion SM Clinical Analyzer, distributed in Texas. The recall was initiated on 1 Feb 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1202-2021
- FDA event ID
- 87309
- Recalling firm
- Thermo Fisher Scientific, Vantaa
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Feb 2021
- FDA classified
- 10 Mar 2021
- Reported
- 17 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Feb 2021 | Recall initiated by company | |
| 10 Mar 2021 | Classified by FDA | +37 days |
| 17 Mar 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Where it was distributed
U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom
Questions about this recall
Is Cascadion SM Clinical Analyzer recalled?
Yes. Thermo Fisher Scientific recalled Cascadion SM Clinical Analyzer on 1 Feb 2021. The recall is Class II and its status is Terminated. Recall number Z-1202-2021.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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