Data Foundry

Medical device recalls 2013

Oxoid Antimicrobial Susceptibility Test Discs F300 — Class III medical device recall Z-2081-2013

Terminated recall by Remel Inc, reported 2013-09-04, distributed in AL, AR, CA, FL, GA, IL, KS, LA…. Use of affected lots may give false indication of susceptibility to Nitrofurantoin.

Recall numberZ-2081-2013
Product typeMedical device
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmRemel Inc, Lenexa, KS, United States
Recall initiated2013-03-25
Classified2013-08-26
Reported by FDA2013-09-04
Terminated2014-06-03
DistributedAL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, WA
Quantity60 packages
Lot numbers1194944, 1198342
Model numbersCT0036B

Product

Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.

Reason for recall

Use of affected lots may give false indication of susceptibility to Nitrofurantoin.

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-2081-2013. 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.