Reported Nov 18, 2020 · Terminated
FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and…
Inpeco S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Inpeco S.A. · Via San Gottardo 10 · Lugano · N/A
Is this the product you have?
- FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) 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.
- Lot codes and dates
- The impacted modules are the Aliquoter Modules (lnpeco Part Number FLX-212) with the firmware
- versions listed below or higher- AQMb_3-3-0.H86 - AQMa_3-1-1-8.H86 and AQMb_3-1-1-8.H86 - xAQMb_1-1-0.elf
- System Serial Numbers
93 of 93 codes
FLX.008FLX.0118FLX.064FLX.101FLX.0116FLX.0125FLX.080FLX.0206FLX.0161FLX.0152FLX.012FLX.0121FLX.0155FLX.033FLX.047FLX.0127FLX.0128FLX.0129FLX.074FLX.076FLX.0113FLX.0138FLX.014FLX.015FLX.0164FLX.051FLX.0106FLX.0158FLX.0196FLX.072FLX.0107FLX.0189FLX.0126FLX.0165FLX.0135FLX.017FLX.0114FLX.022FLX.0119FLX.0105FLX.029FLX.0115FLX.031FLX.032FLX.0141FLX.037FLX.020FLX.039FLX.043FLX.102FLX.046FLX.0143FLX.050FLX.0124FLX.0131FLX.056FLX.060FLX.0136FLX.0140FLX.018
- Amount recalled
- 93
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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