Device product
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 - 15¿C. Product Usage: General Purpose Reagent for laboratory use.
Z-2096-2013
Product summary
- Event
- Event 65874
- Status
- Terminated
- Classification
- Class III
- Quantity
- 43 units
- Official record key
device-enforcement:Z-2096-2013
Official wording
Reason: The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the correct mM unit.
Code information: Lot numbers: 10016853, 10017390, 10020343, 10021820 and 10022594. Expiry dates 12/5/2010, 06/15/2012, 09/08,2012, 08/13/2013 and 02/21/2014.
Distribution pattern: USA Nationwide in the state of CA
Derived failure modes
-
Unknown
The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the correct mM unit.