Medical device recalls Moderate risk

Inpeco S.A. recalls FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System

Recall date
February 13, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1798-2018
FDA classification
Class II
Brand / firm
Inpeco S.A.
Sold / distributed
Distributors in 2 states: NY and IL.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System

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