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U.S. Department of Health and Human Services

Medical Device Recalls

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11 to 20 of 29 Results
510(K) Number: K121012
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Product Description
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Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-2... 2 09/16/2020 Inpeco S.A.
Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-2... 2 09/16/2020 Inpeco S.A.
FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and ... 2 09/16/2020 Inpeco S.A.
Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems... 2 06/01/2020 Inpeco S.A.
Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage:... 2 06/01/2020 Inpeco S.A.
FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate mu... 2 06/01/2020 Inpeco S.A.
FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP... 2 05/28/2020 Inpeco S.A.
Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10),... 2 05/28/2020 Inpeco S.A.
Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1... 2 05/28/2020 Inpeco S.A.
FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271,... 2 05/26/2020 Inpeco S.A.
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