FDA-Device2025-12-03Class II
FlexLab (FLX); Version: FLX-217-40;
Inpeco S.A.
Hazard
The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes
Sold states
US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
Affected count
14 units (1 US, 13 OUS)
Manufactured in
Via San Gottardo 10, N/A, Lugano, N/A, Switzerland
Products
FlexLab (FLX); Version: FLX-217-40;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0596-2026Don't want to check this manually?
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