CLASS II Device recall · Reported 3 Jun 2020 · FDA Enforcement Report
Accelerator a3600 Automation System recalled by Inpeco
Inpeco is recalling Accelerator a3600 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-2141-2020
- 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
Accelerator a3600 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
Is Accelerator a3600 Automation System with Advia2120LAS Interface Module ( recalled?
Yes. Inpeco recalled Accelerator a3600 Automation System with Advia2120LAS Interface Module ( on 7 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2141-2020.
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: ACP.290 ACP.343 ACP.365
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 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.
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