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U.S. Department of Health and Human Services

Class 3 Device Recall Oligonucleotide Ligation Assay Buffer

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  Class 3 Device Recall Oligonucleotide Ligation Assay Buffer see related information
Date Initiated by Firm July 12, 2013
Date Posted August 26, 2013
Recall Status1 Terminated 3 on October 01, 2013
Recall Number Z-2096-2013
Recall Event ID 65874
Product Classification Reagent, general purpose - Product Code LDT
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.
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.
Recalling Firm/
Manufacturer		 Celera Corporation
1401 Harbor Bay Pkwy
Alameda CA 94502-7070
For Additional Information Contact Susan M. Schneider
510-749-4357
Manufacturer Reason
for Recall		 The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the correct mM unit.
FDA Determined
Cause 2		 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 in Commerce 43 units
Distribution USA Nationwide in the state of CA
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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