Exact FDA event identifier

Event 85454

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: April 07, 2020
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Inpeco S.A.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - 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.

Z-2003-2020

Recall number: Z-2003-2020
Initiated: April 07, 2020
Classification: Class II
Status: Terminated
Recalling firm: Inpeco S.A.
Quantity: 82

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Numbers: AML.001, FLX.0104, FLX.0105, FLX.0106, FLX.0107, FLX.0108, FLX.0112, FLX.0114, FLX.0115, FLX.0116, FLX.0118, FLX.0119, FLX.0120, FLX.0124, FLX.0125, FLX.0126, FLX.0131, FLX.0133, FLX.0134, FLX.0135, FLX.0136, FLX.0140, FLX.0141, FLX.0142, FLX.0143, FLX.015, FLX.0152, FLX.0155, FLX.0158, FLX.0161, FLX.0163, FLX.0164, FLX.017, FLX.0175, FLX.0178, FLX.018, FLX.0184, FLX.0189, FLX.019, FLX.0196, FLX.020, FLX.021, FLX.023, FLX.026, FLX.027, FLX.030, FLX.032, FLX.033, FLX.038, FLX.040, FLX.044, FLX.045, FLX.047, FLX.051, FLX.052, FLX.053, FLX.054, FLX.055, FLX.058, FLX.059, FLX.063, FLX.064, FLX.065, FLX.066, FLX.067, FLX.068, FLX.071, FLX.072, FLX.074, FLX.075, FLX.076, FLX.077, FLX.079, FLX.080, FLX.081, FLX.091, FLX.092, FLX.095, FLX.099, FLX.101, FLX.102, FLX.103

Distribution pattern

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

device · product 2 of 2

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.

Z-2004-2020

Recall number: Z-2004-2020
Initiated: April 07, 2020
Classification: Class II
Status: Terminated
Recalling firm: Inpeco S.A.
Quantity: 273

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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