FDA Device recall Z-2140-2020
FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01,…
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01,… by Inpeco, citing 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 Au….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2140-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-07 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Inpeco |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Serial Numbers: FLX.005 FLX.006 FLX.011 FLX.0117 FLX.0121 FLX.0124 FLX.0126 FLX.0129 FLX.0133 FLX.0136 FLX.…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2140-2020%22
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