Recall Z-1889-2020— Inpeco S.A.

Name: FDA recall Z-1889-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-07

Class II · Ongoing

Class II FDA medical device recall by Inpeco S.A., initiated 2020-04-07. It names one FDA 510(k) clearance: K121012. Product: Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf. Reason: The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge..

Recalling firm: Inpeco S.A.
Classification: Class II
Status: Ongoing
Initiated: 2020-04-07
Firm location: Lugano, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K121012 — FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.·cleared 2012-08-31

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

Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf

Reason for recall

The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.

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