Recall · FDA
Inpeco S.A.
Inpeco S.A. issued a Class II FDA recall (Z-0595-2026) initiated 2025-10-30: FlexLab (FLX); Version: FLX-217-10;
| Company | Inpeco S.A. |
|---|---|
| Recall number | Z-0595-2026 |
| Classification | Class II |
| Status | Ongoing |
| Category | Devices |
| Initiated | 2025-10-30 |
| Product | FlexLab (FLX); Version: FLX-217-10; |
| Reason | 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. |
FAQ
What did Inpeco S.A. recall?
FlexLab (FLX); Version: FLX-217-10;
Why was Inpeco S.A.'s product 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 proced…