FlexLab recall
FlexLab (FLX); Version: FLX-217-10;
Why was FlexLab recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 07640172340004 Serial number: FLX.0226;
- Product
- FlexLab (FLX); Version: FLX-217-10;
- Recalling firm
- Inpeco S.A.
- Quantity
- 1 unit (OUS only)
- Distribution
- US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
- Recall date
- December 3, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)