Clinical Chemistry Phenobarbital, list number 1E08
Reported: April 24, 2013 Initiated: November 16, 2012 #Z-1118-2013
Product Description
Clinical Chemistry Phenobarbital, list number 1E08
Reason for Recall
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
Details
- Recalling Firm
- Abbott Laboratories, Inc
- Units Affected
- 1289
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Internationally distributed 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.
- Location
- Irving, TX
Frequently Asked Questions
What product was recalled? ▼
Clinical Chemistry Phenobarbital, list number 1E08. Recalled by Abbott Laboratories, Inc. Units affected: 1289.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2013. Severity: Moderate. Recall number: Z-1118-2013.
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