Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc — Class II medical device recall Z-0443-2016
Terminated recall by Remel Inc, reported 2015-12-23, distributed nationwide. Antibiotic concentration may be insufficient which may result in incorrect test results.
| Recall number | Z-0443-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2015-11-06 |
| Classified | 2015-12-17 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2017-02-13 |
| Distributed | Nationwide (US) |
| Lot numbers | 1686823 |
| Model numbers | CT0024B |
| Expiration dates | 2018-06-30 |
Product
Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
Reason for recall
Antibiotic concentration may be insufficient which may result in incorrect test results.
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-0443-2016. 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.