—#118738

Product

SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).

FDA product code: KHP — Acid, Lactic, Enzymatic Method
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Part Number A95550, Lot Number M210077

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution - USA Nationwide and country of Canada.

Timeline

Recall initiated: 2013-05-28
Posted by FDA: 2013-06-27
Terminated: 2014-06-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118738. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.