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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 FirmMarch 24, 2016
Create DateJune 07, 2016
Recall Status1 Terminated 3 on February 13, 2017
Recall NumberZ-1921-2016
Recall Event ID 73658
Product Classification Susceptibility test powders, antimicrobial - Product Code JTT
ProductOxoid 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 ContactGary 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
ActionCustomers were notified by letter beginning on March 24, 2016.
Quantity in Commerce2 units were imported and distributed domestically
DistributionUS distribution in MO.
Total Product Life CycleTPLC 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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