Data Foundry

Medical device recalls 2013

OLA Buffer For Laboratory Use — Class III medical device recall Z-2096-2013

Terminated recall by Celera Corporation, reported 2013-09-04, distributed nationwide. The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the correct mM un

Recall numberZ-2096-2013
Product typeMedical device
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCelera Corporation, Alameda, CA, United States
Recall initiated2013-07-12
Classified2013-08-26
Reported by FDA2013-09-04
Terminated2013-10-01
DistributedNationwide (US)
Quantity43 units
Lot numbers09/08, 10016853, 10017390, 10020343, 10021820, 10022594, 2012
Expiration dates2010-12-05

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 for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2096-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.