medical Class II Updated 2020-11-18

Inpeco S.A. recalls FlexLab (FLX) Automation System with the Aliquoter Module (I

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Global Distribution including: USA and countries of: Algeria, Australia, Azerbaijan, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Finland, France, Germany, Indonesia, Israel, Italy, Libano, Mexico, Netherlands, Philippines, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and United Arab Emirates.
Lot/Code Info: 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: FLX.008 FLX.0118 FLX.064 FLX.101 FLX.0116 FLX.0125 FLX.080 FLX.0206 FLX.0161 FLX.0152 FLX.012 FLX.0121 FLX.0155 FLX.033 FLX.047 FLX.0127 FLX.0128 FLX.0129 FLX.074 FLX.076 FLX.0113 FLX.0138 FLX.014 FLX.015 FLX.0164 FLX.051 FLX.0106 FLX.0158 FLX.0196 FLX.072 FLX.0107 FLX.0189 FLX.0126 FLX.0165 FLX.0135 FLX.017 FLX.0114 FLX.022 FLX.0119 FLX.0105 FLX.029 FLX.0115 FLX.031 FLX.032 FLX.0141 FLX.037 FLX.020 FLX.039 FLX.043 FLX.102 FLX.046 FLX.0143 FLX.050 FLX.0124 FLX.0131 FLX.056 FLX.060 FLX.0136 FLX.0140 FLX.018 FLX.021 FLX.023 FLX.030 FLX.044 FLX.052 FLX.082 FLX.083 FLX.093 FLX.071 FLX.077 TSH.003 FLX.0146 FLX.027 FLX.038 FLX.075 FLX.0160 FLX.0153 FLX.0154 FLX.0157 FLX.0166 FLX.0167 FLX.0170 FLX.0174 FLX.0179 FLX.0180 FLX.0182 FLX.0194 FLX.0183 FLX.0048 FLX.0049 FLX.0109 FLX.0145 FLX.0148
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Related medical Recalls

Boston Scientific Corporation recalls Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Cathete

2022-08-31 · The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

Mckesson Medical-Surgical Inc. Corporate Office recalls MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, w

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

GE Healthcare, LLC recalls (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (

2022-08-31 · Inaccurate Distance and Area measurements with use of Global Stack viewport.

Mckesson Medical-Surgical Inc. Corporate Office recalls B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY,

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.