FDA-Device2018-05-16Class II
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Inpeco S.A.
Hazard
Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.
Sold states
Distributors in 2 states: NY and IL.
Affected count
18
Manufactured in
Via San Gottardo 10, N/A, Lugano, N/A, Switzerland
Products
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1798-2018Don't want to check this manually?
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