CLASS III Device recall · Reported 4 Sep 2013 · FDA Enforcement Report
OLA Buffer For Laboratory Use recalled by Celera
Celera is recalling OLA Buffer For Laboratory Use, distributed nationwide in the US. The recall was initiated on 12 Jul 2013 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2096-2013
- FDA event ID
- 65874
- Recalling firm
- Celera, Alameda, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Jul 2013
- FDA classified
- 26 Aug 2013
- Reported
- 4 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 12 Jul 2013 | Recall initiated by company | |
| 26 Aug 2013 | Classified by FDA | +45 days |
| 4 Sep 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the correct mM unit.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide in the state of CA
Questions about this recall
Is OLA Buffer For Laboratory Use recalled?
Yes. Celera recalled OLA Buffer For Laboratory Use on 12 Jul 2013. The recall is Class III and its status is Terminated. Recall number Z-2096-2013.
Why was it recalled?
The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the correct mM unit.
Which lots are affected?
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.
Where was it sold?
USA Nationwide in the state of CA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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