Clinical Chemistry Phenobarbital — Class II medical device recall Z-1118-2013
Terminated recall by Abbott Laboratories, Inc, reported 2013-04-24, distributed nationwide. Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to i
| Recall number | Z-1118-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Inc, Irving, TX, United States |
| Recall initiated | 2012-11-16 |
| Classified | 2013-04-15 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BS, CA, CH, CL, CW, DE, DK, ES, FR, GB, GR, IE, IT, KR, LB, MX, NL, NO, OM, PT, PY, RS, RU, SA, TR |
| Quantity | 1,289 |
| Reason classes | potency |
| Lot numbers | 52803UN12, 62299UN12, 85773UN12 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1118-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.