Clinical Chemistry Phenobarbital, list number 1E08
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1118-2013.
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
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1118-2013.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1118-2013.
Abbott Laboratories, Inc
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Abbott Laboratories, Inc Recall FAQ
Abbott Laboratories, Inc is the subject of a medical devices safety report: Clinical Chemistry Phenobarbital, list number 1E08. The notice was published on November 16, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 1,289 units are potentially affected.