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Terminated

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

FDA Recall Z-1798-2018 · Posted None

Recalling FirmInpeco S.A.
Recall StatusTerminated
Product CodeJQP
Date Initiated2018-02-13
Date Terminated2019-04-03
Product Quantity18

Reason for Recall

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.

Firm Action

On 2/13/18, distributors were notified by emailed Technical Service Bulletin. The recalling firm also released a Customer Letter to be forwarded to final customers (labs) by distributors. The Customer Letter advised users of the issue and informed that the recalling firm would be visiting sites to upgrade the firmware to resolve the issue. All impacted customers were instructed to complete and return the Receipt Confirmation within 7 days. Contact provided: Giorgia Amabile - Quality Assurance & Regulatory Affairs Manager, [email protected], (+41) 91 9118 258.

Root Cause

Device Design

Distribution Pattern

Distributors in 2 states: NY and IL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121012FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A. · 2012-08-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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