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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Inpeco S.A.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2004-2020
Related Recalls
FlexLab (FLX); Version: FLX-217-40;
Inpeco S.A.
The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes
FlexLab (FLX); Version: FLX-217-10;
Inpeco S.A.
The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes.
The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.