Z-0157-2020Class II

Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401

Name: Z-0157-2020 Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401
Creator: Vital Scientific N.V.
Published: 2012-01-10
License: https://open.fda.gov/license/

VitalScientific / initiated 2012-01-10 / Terminated / root cause: design

FDA source

Vital Scientific N.V. began a recall of Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended... on 2012-01-10. FDA classified it as Class II and gives the reason as "The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0157-2020
Classification: Class II
Status: Terminated
Initiated: 2012-01-10
Posted: 2019-10-16
Terminated: 2024-04-19
Recalling firm: VitalScientific
Product: Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm reached out to consignees via phone to inform them of the affected product.
Quantity in commerce: 5 instruments
Distribution: US Nationwide in the states of NY, and UT
Product codes and lots: serial numbers: 11-7425; 11-7516; 11-7535; 11-7563; 11-7564.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0157-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0154-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-23	2019-10-16
Z-0155-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-23	2019-10-16
Z-0156-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-23	2019-10-16
Z-0157-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-23	2019-10-16
Z-0158-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-23	2019-10-16

Product code JGS

K102647Class IIElitech Clinical Systems Selectra Prom/elical 2/Elitrol I and Elitrol Ii/ast/got 4+1 Sl/potassium, Sodium, Chloride...Elitechgroup Vital Scientific BV / cleared 2011-03-24

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)