Class 3 Device Recall Synchron Systems Synchron Calibrator Multi Calibrator Diskettes

• Date Initiated by Firm: December 15, 2011
• Date Posted: October 22, 2012
• Recall Status: Terminated on December 28, 2012
• Recall Number: Z-0110-2013
• Recall Event ID: 63130
• 510(K)Number: K110251
• Product Classification: Calibrator, multi-analyte mixture - Product Code JIX
• Product: Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600.; ; The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.
• Code Information: Lot M002642
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Clair K. O'Donovan, Ph.D.; 714-961-4483
• Manufacturer Reason for Recall: The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thyroxine (T4) Reagent Calibrator Diskettes.
• FDA Determined Cause: Labeling mix-ups
• Action: Beckman Coulter sent an Urgent Product Correction letter dated December 15, 2011, withan attached Fax Back Response Form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. If customers are currently using Multi Calibrator lot M002642, then they were instructed to verified diskette and discard all Multi Calibrator diskettes lot M002642 and M002642G without a dark green dot. Customers were instructed to complete and return the enclosed Response Form within 10 days. Customers were instructed to contact Beckman Coulter Support Center at http:www.beckmancoulter.com/customersupport/support/ or call (800) 854-3633 in the US and Canada. Outside of the US or Canada, customers were instructed to contact their local Beckman Coulter Representatives. For questions regarding this recall call 714-961-4483.
• Quantity in Commerce: 5746 units total (2729 units in US)
• Distribution: Worldwide distribution: USA (Nationwide) and Internationally to: Afghanistan Angola Australia Bangladesh Belgium Bhutan Brazil Brunei Darussalam Bulgaria Canada China Colombia Costa Rica Cote d'Ivoire Czech Republic Denmark Ecuador Egypt El Salvador Eritrea Ethiopia Finland France French Polynesia Germany Ghana Greece Guatemala Hong Kong India Indonesia Ireland Israel Italy Japan Jordan Kenya Kuwait Lebanon Lesotho Libyan Arab Jamahiriya Lithuania Macao Malawi Malaysia Mexico Morocco Namibia Netherlands New Zealand Nigeria Oman Pakistan Panama Paraguay Philippines Poland Puerto Rico Qatar Reunion Romania Russian Federation Rwanda Saudi Arabia Serbia Singapore Slovakia South Africa Spain Swaziland Sweden Switzerland Taiwan Thailand Tunisia Turkey Uganda United Arab Emirates United Kingdom Viet Nam Zambia Zimbabwe
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JIX and Original Applicant = BECKMAN COULTER, INC.