Class 2 Device Recall Quantase Neonatal Elution Buffer

• Date Initiated by Firm: January 26, 2010
• Date Posted: March 04, 2011
• Recall Status: Terminated on March 17, 2011
• Recall Number: Z-1562-2011
• Recall Event ID: 54551
• 510(K)Number: K000754 K961515 K990644 K990654
• Product Classification: Ninhydrin and L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine - Product Code JNB
• Product: Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2 and 5), Model number 532-5035, included in 532-5036, 532-5037 and 532-5040, Manufactured by Bio-Rad Laboratories, Hercules, CA
• Code Information: Lot numbers (PIN 532-5036)3250768, 32591735, 32592168, 32592634, 32500061, (PIN 532-5037) 32592456, 32592578, (PIN 532-5040) 32590518, 32590766, 32590915, 32591343, 32591734, 32592166, 32592632, 32500060
• Recalling Firm/ Manufacturer: Bio-Rad Laboratories Inc; 4000 Alfred Nobel Dr; Hercules CA 94547-1803
• For Additional Information Contact: Jolene Bartilson; 510-741-6114
• Manufacturer Reason for Recall: Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.
• FDA Determined Cause: Other
• Action: Direct accounts were notified by phone, followed by fax (domestic). Urgent Device Recall notification letters were sent out on January 26, 2010 to subsidiary along with a Bio-Rad customer form to be send to each customer. The letters identified the affected product and explained the reason for the recall. Customers were asked to examine their inventory and quarantine the affected lots listed. In addition, they are to complete and return the enclosed response form according to the instructions provided. Customers are contact their regional Bio-Rad office for Elution Buffer replacement.
• Quantity in Commerce: 714
• Distribution: Worldwide Distribution -- USA, including states of MI and MN and Bio-Rad facilities in Italy, France, Czech Republic, Canada, Argentina, Panama, United Kingdom, Hong Kong, China, Canada, Singapore, India, South Korea, Brazil, and Sweden.
• 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 = JNB; 510(K)s with Product Code = JNB