Z-2096-2013Class III

OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 M) and KCL (300...

Name: Z-2096-2013 OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 M) and KCL (300...
Creator: Celera Corporation
Published: 2013-07-12
License: https://open.fda.gov/license/

Celera Corporation / initiated 2013-07-12 / Terminated / root cause: labeling and UDI

FDA source

Celera Corporation began a recall of 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... on 2013-07-12. FDA classified it as Class III and gives the reason as "The package insert for FG OLA Buffer, GPR displayed the wrong concentration of M instead of the correct mM unit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2096-2013
Classification: Class III
Status: Terminated
Initiated: 2013-07-12
Posted: 2013-08-26
Terminated: 2013-10-01
Recalling firm: Celera Corporation
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 - 15C. Product Usage: General Purpose Reagent for laboratory use.
Product code: LDT
Reason for recall: The package insert for FG OLA Buffer, GPR displayed the wrong concentration of M instead of the correct mM unit.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2096-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2096-2013	Class III	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-26

Product code LDT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)