Z-1562-2011

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

Name: Z-1562-2011 Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2 and 5), Model number...
Creator: Bio-Rad Laboratories Inc
Published: 2010-01-26
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-01-26 / Terminated

FDA source

Bio-Rad Laboratories Inc began a recall of 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... on 2010-01-26. The reason FDA records is "Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1562-2011
Status: Terminated
Initiated: 2010-01-26
Posted: 2011-03-04
Terminated: 2011-03-17
Recalling firm: Bio-Rad Laboratories Inc.
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
Product code: JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Reason for recall: Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.
FDA 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 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.
Product codes and lots: 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

Product code JNB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)