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
FDA Recall Z-1562-2011 · Posted 2011-03-04
Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeJNB
Date Initiated2010-01-26
Date Terminated2011-03-17
Product Quantity714
Reason for Recall
Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K000754QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KITQuantase , Ltd. · 2000-06-19K990644QUANTASE TOTAL GALACTOSE SCREENING ASSAYQuantase , Ltd. · 1999-06-21K990654QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KITQuantase , Ltd. · 1999-06-21K961515QUANTASE PHENYLALANINE ASSAYShield Diagnostics, Ltd. · 1996-06-12
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.