Class 2 Device Recall Variant II thalassemia Short Program Buffers

• Date Initiated by Firm: April 08, 2014
• Date Posted: May 02, 2014
• Recall Status: Terminated on May 30, 2014
• Recall Number: Z-1537-2014
• Recall Event ID: 68016
• 510(K)Number: K991127
• Product Classification: Hemoglobin a2 quantitation - Product Code JPD
• Product: Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.
• Code Information: Catalog number: 270-2103 (250 tests; Reorder pack lot number: 64005302, Expiration: 4/2015; Catalog number: 270-2154 (500 tests) Reorder pack lot number: 64005207, Expiration: 6/2015; 64004750, Expiration: 11/2015
• Recalling Firm/ Manufacturer: Bio-Rad Laboratories, Inc.; 4000 Alfred Nobel Dr; Hercules CA 94547-1803
• For Additional Information Contact: Ebony McKinnies; 510-741-6265
• Manufacturer Reason for Recall: There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.
• FDA Determined Cause: Nonconforming Material/Component
• Action: BIO-RAD Laboratories sent an URGENT: MEDICAL DEVICE LETTER in the US on April 8. 2014 and worldwide with letters sent to customers and subsidiaries on April 14, 2014. Subsidiaries were asked to translate the letter and distribute to all affected customers Custormer were asked to complete a CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM and fax it to the Bio-Rad CSD Regulatory Affairs Department at the number provided to confirm that you have received this important information
• Quantity in Commerce: 457 kits
• Distribution: Worldwide Distrubution ; USA INCLUDING CA, NY, GA, NC, AL, NJ, CT, WA, NY, LA, Il, MA and Internationally to China, Australia, Canada, France, Great Britain, Hong Kong, Thailand, Singapore,and Brazil.
• 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 = JPD