Recall Z-0158-2020— Vital Scientific N.V.

Name: FDA recall Z-0158-2020
Creator: U.S. Food and Drug Administration
Published: 2012-01-10

Class II · Terminated

Class II FDA medical device recall by Vital Scientific N.V., initiated 2012-01-10, terminated 2024-04-19. It names one FDA 510(k) clearance: K102647. Product: Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.. Reason: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced..

Recalling firm: Vital Scientific N.V.
Classification: Class II
Status: Terminated
Initiated: 2012-01-10
Terminated: 2024-04-19
Firm location: Dieren, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K102647 — ELITECH 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

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.