FDAClass IIJune 3, 2020

Accelerator a3600 Automation System with Advia2120LAS recall: Software Issue

Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01…

Why was Accelerator a3600 Automation System with Advia2120LAS recalled?

The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: ACP.290 ACP.343 ACP.365

Product
Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01…
Recalling firm
Inpeco S.A.
Quantity
3 systems
Distribution
US Nationwide including in the states of IL, NY.
Recall date
June 3, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls