medical Class II Updated 2020-06-03

Inpeco S.A. recalls Aptio Automation System with Advia2120LAS Interface Module (

Recalled Product

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 Usage: 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: AP2.0003 AP2.0007 AP2.0008 AP2.0009 AP2.0010 AP2.0017 AP2.0022 AP2.0025 AP2.0036 AP2.0049 AP2.0052 AP2.0057 AP2.0058 AP2.0059 AP2.0064 AP2.0065 AP2.0077 AP2.0082 AP2.0083 AP2.0089 AP2.0090 AP2.0092 AP2.0098 AP2.0100 AP2.0105 AP2.0109 AP2.0110 AP2.0129 AP2.0136 AP2.0149 AP2.0156 AP2.0173 AP2.0179 AP2.0180 AP2.0181 AP2.0193 AP2.0194 AP2.0201 AP2.0202 AP2.0211 AP2.0230 AP2.0233 AP2.0235 AP2.0236 AP2.0238 AP2.0251 AP2.0254 AP2.0258 AP2.0264 AP2.0269 AP2.0270 AP2.0275 AP2.0289 AP2.0295 AP2.0317 AP2.0325 AP2.0332 AP2.0339 AP2.0375 AP2.0381 AP2.0394 AP2.0411 AP2.0427 APT.0009 APT.0014 APT.0058 APT.0065 APT.0091 APT.0136 APT.0247
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