FDA Device recall Z-1118-2013
Clinical Chemistry Phenobarbital, list number 1E08
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of Clinical Chemistry Phenobarbital, list number 1E08 by Abbott Laboratories, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1118-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-16 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
Clinical Chemistry Phenobarbital, list number 1E08
Reason
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
Identifiers
| code_info | Lot Numbers 52803UN12, 62299UN12, and 85773UN12 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1118-2013%22
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