Inpeco S.A.: FlexLab (FLX); Version: FLX-217-40;
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Inpeco S.A.
- Product
- FlexLab (FLX); Version: FLX-217-40;
- Reason / 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
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
- Recall initiated
- 2025-10-30
- Code info
- 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;
- Product quantity
- 14 units (1 US, 13 OUS)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Lugano
- State
- N/A
- Country
- Switzerland
- Event id
- 97887
Free daily digest + "My products" watchlist