UniCel DxC and Synchron LX Clinical Systems 100 L Sample Syringe, 100UL-PKGD, Part Number 474171 Product Usage: The UniC

FDA device recall Z-0452-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The recall was initiated because Beckman Coulter has confirmed that the Modular Chemistry (MC) and Cartridge Chemistry (CC) 100 uL sample syringes may experience premature wear as indicated by brown discoloration on the plunger and/or inside the glass syringe barrel. Excessive wear of the 100 uL sample syringe barrel and plunger could lead to leaking and may affect results.

Action taken

Beckman Coulter sent an URGENT: Product Corrective Action letter to all affected customers. The letter provided customers with an explanation of the problem identified and actions to be taken. The letter instructs customers to share this information with their laboratory staff and retain a copy as part of their laboratory Quality System documentation. In addition, the letter states that if the affected product was further distributed to provide a copy of the letter to them. Customers were also asked to complete and return the enclosed Response Form. For any questions contact Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the United States and Canada.

Root cause

Component design/selection

Status

Terminated

Product code

JJE

Quantity affected

3278 total (3083 in US, 195 in Canada)

Distribution

Worldwide Distribution - USA (nationwide) and the country of Canada.

Date initiated

2010-09-02

Date posted

2012-01-11

Date terminated

2014-06-30

Location

Brea, CA