Celera OLA Buffer Recalled for Incorrect Concentration Units
Celera Corporation is recalling OLA Buffer for Laboratory Use because the package insert listed the wrong concentration units.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding units of measurement.
Plain-English summary
Celera Corporation is recalling 43 units of OLA Buffer for Laboratory Use. The product is a general-purpose reagent containing MgCl2 and KCL, intended for laboratory use only.
The recall was initiated because the package insert displayed the wrong concentration unit, listing 'µM' instead of the correct 'mM'. This labeling error could lead to incorrect usage of the reagent in laboratory settings.
The affected units were distributed nationwide in the state of California. Users should stop using the product and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Celera Corporation
- Hazard
- Affected units
- 43
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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.
Distribution
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