CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report
FlexLab (FLX) recalled by Inpeco
Inpeco is recalling FlexLab (FLX), distributed nationwide in the US. The recall was initiated on 30 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0596-2026
- FDA event ID
- 97887
- Recalling firm
- Inpeco, Lugano, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Oct 2025
- FDA classified
- 25 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Oct 2025 | Recall initiated by company | |
| 25 Nov 2025 | Classified by FDA | +26 days |
| 3 Dec 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
FlexLab (FLX); Version: FLX-217-40;
Where it was distributed
US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
Questions about this recall
Is FlexLab (FLX) recalled?
Yes. Inpeco recalled FlexLab (FLX) on 30 Oct 2025. The recall is Class II and its status is Ongoing. Recall number Z-0596-2026.
Why was it 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
Which lots are affected?
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;
Where was it sold?
US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Inpeco
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | FlexLab (FLX) recalled by Inpeco | Inpeco | Other | Nationwide |
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