Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2 and 5), Model number 532-5035,

FDA device recall Z-1562-2011 · posted 2011-03-04 · Terminated

Recall details

Recalling firm

Bio-Rad Laboratories Inc

Reason for recall

Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.

Action taken

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

Status

Terminated

Product code

JNB

Quantity affected

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, In

Date initiated

2010-01-26

Date posted

2011-03-04

Date terminated

2011-03-17

Location

Hercules, CA

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