Reported Jun 3, 2020 · Terminated
Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface…
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 · N/A
Is this the product you have?
- Aptio 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) - Product Usageis 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
- Serial Numbers
70 of 70 codes
AP2.0003AP2.0007AP2.0008AP2.0009AP2.0010AP2.0017AP2.0022AP2.0025AP2.0036AP2.0049AP2.0052AP2.0057AP2.0058AP2.0059AP2.0064AP2.0065AP2.0077AP2.0082AP2.0083AP2.0089AP2.0090AP2.0092AP2.0098AP2.0100AP2.0105AP2.0109AP2.0110AP2.0129AP2.0136AP2.0149AP2.0156AP2.0173AP2.0179AP2.0180AP2.0181AP2.0193AP2.0194AP2.0201AP2.0202AP2.0211AP2.0230AP2.0233AP2.0235AP2.0236AP2.0238AP2.0251AP2.0254AP2.0258AP2.0264AP2.0269AP2.0270AP2.0275AP2.0289AP2.0295AP2.0317AP2.0325AP2.0332AP2.0339AP2.0375AP2.0381
- Serial Numbers
- Amount recalled
- 70 systems
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was 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.
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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