CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report

Abbott Accelerator a3600, Architect cSystem c8000/c16000 recalled

Inpeco is recalling Abbott Accelerator a3600, Architect cSystem c8000/c16000 Interface Module, Part Numbers, distributed nationwide in the US. The recall was initiated on 7 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: ACP.001, ACP.002, ACP.003, ACP.004, ACP.007, ACP.008, ACP.010, ACP.011, ACP.013, ACP.014, ACP.015, ACP.016, ACP.017, ACP.018, ACP.019, ACP.020, ACP.022, ACP.023, ACP.024, ACP.025, ACP.026, ACP.027, ACP.028, ACP.029, ACP.030, ACP.031, ACP.032, ACP.033, ACP.034, ACP.035, ACP.036, ACP.038, ACP.041, ACP.042, ACP.043, ACP.044, ACP.045, ACP.046, ACP.047, ACP.048, ACP.049, ACP.050, ACP.051, ACP.052, ACP.053, ACP.055, ACP.056, ACP.057, ACP.058, ACP.059, ACP.060, ACP.061, ACP.063, ACP.064, ACP.066, ACP.067, ACP.068, ACP.069, ACP.070, ACP.071, ACP.072, ACP.073, ACP.074, ACP.075, ACP.076, ACP.078, ACP.079, ACP.080, ACP.081, ACP.082, ACP.084, ACP.085, ACP.086, ACP.088, ACP.090, ACP.092, ACP.093, ACP.094, ACP.096, ACP.098, ACP.099, ACP.100, ACP.101, ACP.102, ACP.103, ACP.104, ACP.105, ACP.106, ACP.109, ACP.110, ACP.111, ACP.113, ACP.114, ACP.115, ACP.116, ACP.117, ACP.118, ACP.119, ACP.120, ACP.121, ACP.122, ACP.123, ACP.124, ACP.125, ACP.127, ACP.128, ACP.129, ACP.130, ACP.131, ACP.132, ACP.133, ACP.134, ACP.135, ACP.137, ACP.138, ACP.139, ACP.140, ACP.141, ACP.142, ACP.143, ACP.145, ACP.146, ACP.147, ACP.148, ACP.149, ACP.151, ACP.152, ACP.154, ACP.155, ACP.156, ACP.157, ACP.158, ACP.159, ACP.160, ACP.161, ACP.162, ACP.163, ACP.164, ACP.165, ACP.166, ACP.167, ACP.168, ACP.169, ACP.170, ACP.171, ACP.172, ACP.173, ACP.174, ACP.175, ACP.176, ACP.177, ACP.178, ACP.181, ACP.182, ACP.190, ACP.191, ACP.193, ACP.195, ACP.196, ACP.197, ACP.198, ACP.199, ACP.200, ACP.201, ACP.203, ACP.204, ACP.205, ACP.206, ACP.207, ACP.209, ACP.210, ACP.211, ACP.212, ACP.213, ACP.215, ACP.216, ACP.217, ACP.218, ACP.219, ACP.220, ACP.221, ACP.222, ACP.223, ACP.224, ACP.225, ACP.227, ACP.228, ACP.229, ACP.231, ACP.232, ACP.234, ACP.236, ACP.237, ACP.239, ACP.240, ACP.241, ACP.242, ACP.243, ACP.244, ACP.245, ACP.246, ACP.247, ACP.254, ACP.255, ACP.257, ACP.259, ACP.260, ACP.261, ACP.265, ACP.267, ACP.272, ACP.276, ACP.278, ACP.279, ACP.280, ACP.281, ACP.283, ACP.285, ACP.287, ACP.289, ACP.292, ACP.293, ACP.294, ACP.299, ACP.300, ACP.301, ACP.303, ACP.304, ACP.306, ACP.307, ACP.308, ACP.309, ACP.316, ACP.317, ACP.319, ACP.320, ACP.321, ACP.322, ACP.324, ACP.325, ACP.326, ACP.327, ACP.329, ACP.332, ACP.333, ACP.337, ACP.341, ACP.342, ACP.345, ACP.346, ACP.347, ACP.350, ACP.351, ACP.352, ACP.359, ACP.374, ACP.377, ACP.383, ACP.390, ACP.391, ACP.392, ACP.402, ACP.404, ACP.411, ACP.412, ACP.416, ACP.421, ACP.422, ACP.428, ACP.430, ACP.434, ACP.441, ACP.442

Quantity recalled273

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2004-2020
FDA event ID: 85454
Recalling firm: Inpeco, Lugano, N/A
Classification: Class II
Status: Terminated
Recall initiated: 7 Apr 2020
FDA classified: 14 May 2020
Reported: 20 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

7 Apr 2020	Recall initiated by company
14 May 2020	Classified by FDA	+37 days
20 May 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.

Product as listed by the FDA

Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) 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.

Where it was distributed

Worldwide distribution - US Nationwide including in the states of Texas, West Virginia, South Carolina, Delaware, Louisiana, Illinois, Georgia, Florida, New York, Virginia, Arkansas, Wisconsin, California, Minnesota, Missouri, North Carolina, Utah, Michigan, Ohio, Alabama, Oklahoma, Tennessee, Kansas, Hawaii, Arizona, Washington

Nationwide Alabama Arkansas Arizona California Delaware Florida Georgia Hawaii Illinois Kansas Louisiana Michigan Minnesota Missouri North Carolina New York Ohio Oklahoma South Carolina Tennessee

Questions about this recall

Why was it recalled?

When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.

Which lots are affected?

Serial Numbers: ACP.001, ACP.002, ACP.003, ACP.004, ACP.007, ACP.008, ACP.010, ACP.011, ACP.013, ACP.014, ACP.015, ACP.016, ACP.017, ACP.018, ACP.019, ACP.020, ACP.022, ACP.023, ACP.024, ACP.025, ACP.026, ACP.027, ACP.028, ACP.029, ACP.030, ACP.031, ACP.032, ACP.033, ACP.034, ACP.035, ACP.036, ACP.038, ACP.041, ACP.042, ACP.043, ACP.044, ACP.045, ACP.046, ACP.047, ACP.048, ACP.049, ACP.050, ACP.051, ACP.052, ACP.053, ACP.055, ACP.056, ACP.057, ACP.058, ACP.059, ACP.060, ACP.061, ACP.063, ACP.064, ACP.066, ACP.067, ACP.068, ACP.069, ACP.070, ACP.071, ACP.072, ACP.073, ACP.074, ACP.075, ACP.076, ACP.078, ACP.079, ACP.080, ACP.081, ACP.082, ACP.084, ACP.085, ACP.086, ACP.088, ACP.090, ACP.092, ACP.093, ACP.094, ACP.096, ACP.098, ACP.099, ACP.100, ACP.101, ACP.102, ACP.103, ACP.104, ACP.105, ACP.106, ACP.109, ACP.110, ACP.111, ACP.113, ACP.114, ACP.115, ACP.116, ACP.117, ACP.118, ACP.119, ACP.120, ACP.121, ACP.122, ACP.123, ACP.124, ACP.125, ACP.127, ACP.128, ACP.129, ACP.130, ACP.131, ACP.132, ACP.133, ACP.134, ACP.135, ACP.137, ACP.138, ACP.139, ACP.140, ACP.141, ACP.142, ACP.143, ACP.145, ACP.146, ACP.147, ACP.148, ACP.149, ACP.151, ACP.152, ACP.154, ACP.155, ACP.156, ACP.157, ACP.158, ACP.159, ACP.160, ACP.161, ACP.162, ACP.163, ACP.164, ACP.165, ACP.166, ACP.167, ACP.168, ACP.169, ACP.170, ACP.171, ACP.172, ACP.173, ACP.174, ACP.175, ACP.176, ACP.177, ACP.178, ACP.181, ACP.182, ACP.190, ACP.191, ACP.193, ACP.195, ACP.196, ACP.197, ACP.198, ACP.199, ACP.200, ACP.201, ACP.203, ACP.204, ACP.205, ACP.206, ACP.207, ACP.209, ACP.210, ACP.211, ACP.212, ACP.213, ACP.215, ACP.216, ACP.217, ACP.218, ACP.219, ACP.220, ACP.221, ACP.222, ACP.223, ACP.224, ACP.225, ACP.227, ACP.228, ACP.229, ACP.231, ACP.232, ACP.234, ACP.236, ACP.237, ACP.239, ACP.240, ACP.241, ACP.242, ACP.243, ACP.244, ACP.245, ACP.246, ACP.247, ACP.254, ACP.255, ACP.257, ACP.259, ACP.260, ACP.261, ACP.265, ACP.267, ACP.272, ACP.276, ACP.278, ACP.279, ACP.280, ACP.281, ACP.283, ACP.285, ACP.287, ACP.289, ACP.292, ACP.293, ACP.294, ACP.299, ACP.300, ACP.301, ACP.303, ACP.304, ACP.306, ACP.307, ACP.308, ACP.309, ACP.316, ACP.317, ACP.319, ACP.320, ACP.321, ACP.322, ACP.324, ACP.325, ACP.326, ACP.327, ACP.329, ACP.332, ACP.333, ACP.337, ACP.341, ACP.342, ACP.345, ACP.346, ACP.347, ACP.350, ACP.351, ACP.352, ACP.359, ACP.374, ACP.377, ACP.383, ACP.390, ACP.391, ACP.392, ACP.402, ACP.404, ACP.411, ACP.412, ACP.416, ACP.421, ACP.422, ACP.428, ACP.430, ACP.434, ACP.441, ACP.442

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 85454

This product is part of a recall event; the main page for the event is FlexLab, Architect cSystem c8000/c16000 Interface Module recalled.

Reported	Class	Recall	Company	Reason	Where
20 May 2020	CLASS II	FlexLab, Architect cSystem c8000/c16000 Interface Module recalled	Inpeco	Other	Nationwide

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