PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: May 16, 2018 Initiated: February 13, 2018 #Z-1798-2018

Product Description

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

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.

Details

Recalling Firm
Inpeco S.A.
Units Affected
18
Distribution
Distributors in 2 states: NY and IL.
Location
Lugano, N/A

Frequently Asked Questions

What product was recalled?
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System. Recalled by Inpeco S.A.. Units affected: 18.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1798-2018.