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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 µM) and KCL (300 µM. 10.0ml.) PN: 50003300; Store at d - 15°C. Product Usage: General Purpose Reagent for laboratory use.
Recall Number Z-2096-2013
Classification Class III
Code Info 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.
Product Distributed Qty 43 units
Reason For Recall The package insert for FG OLA Buffer, GPR displayed the wrong concentration of µM instead of the correct mM unit.

Event Detail

Event Id 65874
Product Type Devices
Status Ongoing
Recalling Firm Celera Corporation
City Alameda
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide in the state of CA