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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description 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.
Recall Number Z-2081-2013
Classification Class III
Code Info Lots 1194944 and 1198342
Product Distributed Qty 60 packs
Reason For Recall Use of affected lots may give false indication of susceptibility to Nitrofurantoin.

Event Detail

Event Id 64852
Product Type Devices
Status Ongoing
Recalling Firm Remel Inc
City Lenexa
State KS
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution including the states of AL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, and WA.