Inpeco S.A.: FlexLab (FLX); Version: FLX-217-40;

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

Details from the source

Reason for recall: 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 Distribution: US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK. Quantity: 14 units (1 US, 13 OUS) Lot/code info: UDI-DI: 07640172344002; Serial number: FXX.0004, FXX.0006, FXX.0009, FXX.0022, FXX.0023, FXX.0024, FXX.0027, FXX.0028, FXX.0034, FXX.0036, FXX.0041, FXX.0042, FXX.0043, FXX.0046;

UPC codes

07640172344002

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.