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U.S. Department of Health and Human Services

Class 2 Device Recall Oxoid Nitrocefin ( Reconstitution Fluid Batch)

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  Class 2 Device Recall Oxoid Nitrocefin ( Reconstitution Fluid Batch) see related information
Date Initiated by Firm March 24, 2016
Create Date June 07, 2016
Recall Status1 Terminated 3 on February 13, 2017
Recall Number Z-1921-2016
Recall Event ID 73658
Product Classification Susceptibility test powders, antimicrobial - Product Code JTT
Product Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic
Code Information Lot 1717357 Exp: 31Aug2017
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Gary L. Klaassen
913-895-4077
Manufacturer Reason
for Recall		 Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers were notified by letter beginning on March 24, 2016.
Quantity in Commerce 2 units were imported and distributed domestically
Distribution US distribution in MO.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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