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U.S. Department of Health and Human Services

Class 2 Device Recall Quantase Neonatal Elution Buffer

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  Class 2 Device Recall Quantase Neonatal Elution Buffer see related information
Date Initiated by Firm January 26, 2010
Date Posted March 04, 2011
Recall Status1 Terminated 3 on March 17, 2011
Recall Number Z-1562-2011
Recall Event ID 54551
510(K)Number K961515  K990644  K990654  K000754  
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 2		 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 and Original Applicant = QUANTASE LTD.
510(K)s with Product Code = JNB and Original Applicant = SHIELD DIAGNOSTICS, LTD.
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