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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 Recall
Quantase Neonatal Elution Buffer
see related information
Date Posted March 04, 2011
Recall Status1 Terminated on March 17, 2011
Recall Number Z-1562-2011
Recall Event ID 54551
Premarket Notification
510(K) Numbers
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/
Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules, California 94547-1803
For Additional Information Contact Jolene Bartilson
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
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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.