[pending] FlexLab (FLX); Version: FLX-217-10;
Pending LLM rewrite. Source: FDA_DEVICE Z-0595-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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 recalled product
- Product
- FlexLab (FLX); Version: FLX-217-10;
- Manufacturer
- Inpeco S.A.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 07640172340004 Serial number: FLX.0226
Distribution
Distributed in 1 state:
- MI
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