Recall Z-1613-2013
Beckman Coulter Inc. · initiated May 28, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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).
Codes / lots: Part Number A95550, Lot Number M210077
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.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-1613-2013
- Initiated
- May 28, 2013
- Posted by FDA
- June 27, 2013
- Terminated
- June 3, 2014
- Product code
- KHP – Acid, Lactic, Enzymatic Method
- Quantity
- 3,353 units
- Distribution
- Worldwide Distribution - USA Nationwide and country of Canada.
- Recalling firm
- Beckman Coulter Inc., Brea, CA