FDAClass IINovember 20, 2013

Access 2 Immunoassay System recall

Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative…

Why was Access 2 Immunoassay System recalled?

Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.

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: 508801, 508802, 508803, 508804, 508805, 508806, 508807, 508810

Product
Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative…
Recalling firm
Beckman Coulter Inc.
Quantity
8 units total (1 unit in the US)
Distribution
Worldwide distribution: US (nationwide) in the state of: TX and countries of: Colombia, Hong Kong and Korea.
Recall date
November 20, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls