UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide prepar

FDA device recall Z-2225-2012 · posted 2012-08-20 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were missing vinyl caps, exposing sharpt edges on the DxH Slidemaker Stainer Reagent Cabinet (Floor Stand) drawer slides. The sharp edges on the drawer slides may expose operators to physical injury when replacing reagents and waste containers whic

Action taken

Beckman Coulter initiated a "PRODUCT CORRECTIVE ACTION (PCA)" which was communicated via phone calls starting the week of December 19, 2011 to all customers who purchased UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System. The phone calls provided the customers with an explanation of the problem identified, potential impact should the problem occur and an action to be taken. Customers were instructed to share the PCA information with their laboratory staff and if they had any questions, they should contact Beckman Coulter at (800) 526-7694.

Root cause

Process change control

Status

Terminated

Product code

CKG

Quantity affected

41 units (15 units in the US)

Distribution

Worldwide Distribution-USA (nationwide) including the states GA, NY, IL, TX, WA, PA, IN, MS, NC, and MO and the countries of Belgium, France, Hong Kong, Italy, Spain, and Switzerland.

Date initiated

2011-12-13

Date posted

2012-08-20

Date terminated

2012-08-20

Location

Brea, CA