United StatesFlexLab (FLX) Version FLX-217-10 and FLX-217-40 units are affected; identified UDI-DI 07640172340004 (serial FLX.0226) and UDI-DI 07640172344002 (serials 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). The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels if operators open the mALX printer head for error recovery or maintenance and do not empty the printer tubes buffer, which may result in delayed or erroneous results.
What's being recalled
FlexLab (FLX); Version: FLX-217-10;
FlexLab (FLX); Version: FLX-217-40;
Recalling firm: Inpeco S.A., Lugano, N/A, Switzerland.
How to identify it
UDI-DI: 07640172340004 Serial number: FLX.0226; 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;
The 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.
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
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)