FlexLab (FLX); Version: FLX-217-40;
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 30, 2025 |
| Reported | December 03, 2025 |
| Recalling firm | Inpeco S.A. |
| Country / region | Switzerland N/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
Affected products
- FlexLab (FLX); Version: FLX-217-40;
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