FDA Recall Terminated

OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 M) and KCL (300 M. 10.0ml.) PN: 50003300; Store at d - 15C. Product Usage: General Purpose Reagent for laboratory use.

Recall: Z-2096-2013 · Initiated July 12, 2013

Recall

Recall Number
Z-2096-2013
Event Number
65874
Firm
Celera Corporation
FEI Number
3004008801
Product Code
LDT
Status
Terminated
Root Cause
Error in labeling
Initiated
July 12, 2013
Posted
August 26, 2013
Terminated
October 1, 2013
Address
1401 Harbor Bay Pkwy, Alameda, CA, 94502-7070

Description

OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 M) and KCL (300 M. 10.0ml.) PN: 50003300; Store at d - 15C. Product Usage: General Purpose Reagent for laboratory use.

Reason

The package insert for FG OLA Buffer, GPR displayed the wrong concentration of M instead of the correct mM unit.

Action

Celera sent a customer notification letter dated July 12, 2013 by e-mail and mailed on July 19, 2013 via first class mail to all affected customers. The letter identified the affected product, problem and actions to be taken. The information is being provided for records and assures customer that there were not quality issues with the product and it may be used as usual in laboratory test procedures. For questions call 1-810-749-4200 or contact your local authorized Celera representative.

Distribution

USA Nationwide in the state of CA

Quantity

43 units