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Terminated

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 - 15C. Product Usage: General Purpose Reagent for laboratory use.

FDA Recall Z-2096-2013 · Posted 2013-08-26

Recalling FirmCelera Corporation
Recall StatusTerminated
Product CodeLDT
Date Initiated2013-07-12
Date Terminated2013-10-01
Product Quantity43 units

Reason for Recall

The package insert for FG OLA Buffer, GPR displayed the wrong concentration of M instead of the correct mM unit.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

USA Nationwide in the state of CA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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