Recall Z-1562-2011 ยท JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Bio-Rad Laboratories Inc
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
| Date | Mar 4, 2011 (initiated Jan 26, 2010) |
| Status | Terminated |
| Reason | Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury. |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000754 | QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT Quantase , Ltd., Jun 19, 2000 |
| K961515 | QUANTASE PHENYLALANINE ASSAY Shield Diagnostics, Ltd., Jun 12, 1996 |
| K990644 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY Quantase , Ltd., Jun 21, 1999 |
| K990654 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT Quantase , Ltd., Jun 21, 1999 |