Recall Z-2096-2013— Celera Corporation
Class III · Terminated
Class III FDA medical device recall by Celera Corporation, initiated 2013-07-12, terminated 2013-10-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the correct mM unit..
- Recalling firm
- Celera Corporation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-07-12
- Terminated
- 2013-10-01
- Firm location
- Alameda, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.