Class 2 Device Recall Beckman Coulter HbA1c APT

• Date Initiated by Firm: March 01, 2011
• Date Posted: May 10, 2011
• Recall Status: Terminated on June 28, 2012
• Recall Number: Z-2170-2011
• Recall Event ID: 58168
• 510(K)Number: K031380
• Product Classification: Assay, glycoslylated hemoglobin - Product Code LCP
• Product: Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177, Lot Numbers: 9390 & 9472; Immuno-inhibition test for the quantitative determination of HbA1c (Hemoglobin A1c), in human whole blood, on the Beckman Coulter AU680 with whole blood automated pretreatment (APT) capability only. For in vitro diagnostic use only. The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio, and must not be used individually for diagnostic purposes.
• Code Information: Lot Numbers: 9390 & 9472
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 200 S Kraemer Blvd; Brea CA 92821-6208
• For Additional Information Contact: Clair K. ODonovan, Ph.D.; 714-961-4483
• Manufacturer Reason for Recall: The recall was initiated because Beckman Coulter has identified a problem with two lots of HbA1c APT reagent OSR61177. When HbA1c APT reagent lots 9390 and 9472 are calibrated with HbA1c calibrator ODR3032, elevated recovery may be observed for patient samples. Falsely elevated HbA1c values may be interpreted as increased risk for diabetes or poorly controlled diabetes. Consequent medical acti
• FDA Determined Cause: Pending
• Action: Beckman Coulter initiated the recall communication with a Product Corrective Action (PCA) letter with attached recall response form on March 1, 2011 to the affected customers. The letter explained the problem and identified the action to be taken. The PCA also instructed the consignees to: (1) Please discontinue the use of lots 9390 and 9472 and discard according to your local procedures. (2) Please contact your local Beckman Coulter support Organization for replacement reagent. (3) You may need to re-evaluate samples for HbA1c which were tested with either of the listed lots of reagent. In addition, customers were instructed to: (1) share the information with their laboratory staff and retain this notification as part of their Quality System documentation. If any of the affected product was forwarded to another laboratory, a copy of the letter should be provided to them. (2) complete and return the enclosed response form within 10 days so that the firm was assured the customer received the important communication. For any questions regarding this notice, customers were instructed to contact Customer Technical Support at 1-800-854-3633 in the U.S.A and at 00353656831111 in Europe.
• Quantity in Commerce: 373 kits
• Distribution: Worldwide Distribution - USA (Nationwide) Austria, Croatia, France, Germany, Korea, Philippines, Russian Federation, Thailand, Venezuela, and Vietnam.
• 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 = LCP and Original Applicant = OLYMPUS AMERICA, INC.