Z-2096-2013 Class III Terminated
FDA device recall Z-2096-2013 was initiated by Celera Corporation on July 12, 2013 and is designated Class III. Reason for recall: The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the correct mM unit. The recall status is terminated (terminated October 1, 2013). Affected quantity: 43 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2013
- Initiation Date
- July 12, 2013
- Termination Date
- October 1, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43 units
Product 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 - 15¿C. Product Usage: General Purpose Reagent for laboratory use.
Reason for Recall
The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the correct mM unit.
Distribution Pattern
USA Nationwide in the state of CA
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.