CLASS II Device recall · Reported 3 Jun 2020 · FDA Enforcement Report
FlexLab Automation System with Advia2120LAS Interface Module recalled
Inpeco is recalling FlexLab Automation System with Advia2120LAS Interface Module (, distributed nationwide in the US. The recall was initiated on 7 Apr 2020 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-2140-2020
- FDA event ID
- 85444
- Recalling firm
- Inpeco, Lugano, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Apr 2020
- FDA classified
- 28 May 2020
- Reported
- 3 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 7 Apr 2020 | Recall initiated by company | |
| 28 May 2020 | Classified by FDA | +51 days |
| 3 Jun 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
Where it was distributed
US Nationwide including in the states of IL, NY.
Questions about this recall
Why was it recalled?
The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.
Which lots are affected?
Serial Numbers: FLX.005 FLX.006 FLX.011 FLX.0117 FLX.0121 FLX.0124 FLX.0126 FLX.0129 FLX.0133 FLX.0136 FLX.0139 FLX.0140 FLX.0147 FLX.0149 FLX.0153 FLX.0157 FLX.016 FLX.0165 FLX.0168 FLX.0173 FLX.0189 FLX.0191 FLX.0192 FLX.022 FLX.030 FLX.032 FLX.035 FLX.036 FLX.037 FLX.050 FLX.056 FLX.060 FLX.062 FLX.065 FLX.082 FLX.096 SHD.002
Where was it sold?
US Nationwide including in the states of IL, NY.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 85444This product is part of a recall event; the main page for the event is Accelerator a3600 Automation System recalled by Inpeco.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Accelerator a3600 Automation System recalled by Inpeco | Inpeco | Device Malfunction | Nationwide | |
| CLASS II | Aptio Automation System with Advia2120LAS Interface Module recalled | Inpeco | Device Malfunction | Nationwide |
More recalls from Inpeco
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | FlexLab (FLX) recalled by Inpeco | Inpeco | Other | MI |
| Device | CLASS II | FlexLab (FLX) recalled by Inpeco | Inpeco | Other | MI |
| Device | CLASS II | FlexLab (FLX) System recalled by Inpeco | Inpeco | Other | CA, NY |
| Device | CLASS II | FlexLab X (FXX) System recalled by Inpeco | Inpeco | Other | CA, NY |
| Device | CLASS II | Roche Cobas 8000 and Cobas PRO Interface Module recalled by Inpeco | Inpeco | Other | Nationwide |
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