Recall Z-2096-2013 ยท LDT
Celera Corporation
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.
| Date | Aug 26, 2013 (initiated Jul 12, 2013) |
| Status | Terminated |
| Reason | The package insert for FG OLA Buffer, GPR displayed the wrong concentration of M instead of the correct mM unit. |
| Root cause | Error in labeling |
| 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. |
| Quantity | 43 units |
| Distribution | USA Nationwide in the state of CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.