Abbott Recalls Phenobarbital Reagent Lots Due to Imprecision Issues
Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots due to imprecision issues that increase with the age of the reagent.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, fitting the criteria for a moderate severity recall involving a quality defect without reported harm.
Plain-English summary
Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however, internal testing confirmed CVs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803UN12 is now expired, it exhibit
The recall involves 1,289 units distributed nationwide in the USA and internationally to Argentina, Australia, Austria, Bahamas, Brunei, Canada, Chile, Curacao, Denmark, France, Germany, Greece, Ireland, Italy, Lebanon, Mexico, Netherlands, Norway, Oman, Paraguay, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, South Korea, Spain, Switzerland, Turkey, and United Kingdom. The affected lot numbers are 52803UN12, 62299UN12, and 85773UN12.
Consumers and healthcare facilities should check their inventory for these specific lot numbers and stop using the affected reagents. They should contact Abbott Laboratories, Inc for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Clinical Chemistry Phenobarbital, list number 1E08
- Manufacturer
- Abbott Laboratories, Inc
- Affected units
- 1,289
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 (3)
- Lot Numbers 52803UN12
- 62299UN12
- and 85773UN12
Distribution
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