SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron

FDA device recall Z-1613-2013 · posted 2013-06-27 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with error condition OCR LOW. The calibration failures appear to be related to improper shipping or storage conditions (frozen reagent). Failed calibration of LACT may cause a delay in reporting results.

Action taken

Beckman Coulter Inc. sent an Urgent Product Correction letter dated May 28, 2013 to affected customers. The letter identified the affected product, the issue, impact, actions to be taken, and resolution. The letter instructed customers to discontinue use of the affected product and request a replacement product. For 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. Outside the United States or Canada, contact your local Beckman Coulter Representative.

Root cause

Under Investigation by firm

Status

Terminated

Product code

KHP

Quantity affected

3,353 units

Distribution

Worldwide Distribution - USA Nationwide and country of Canada.

Date initiated

2013-05-28

Date posted

2013-06-27

Date terminated

2014-06-03

Location

Brea, CA