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U.S. Department of Health and Human Services

Class 2 Device Recall MicroScan Pos Combo Panel Type 43,Panels, test, susceptibility, antimicrobial Catalog number B1017217

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 Class 2 Device Recall MicroScan Pos Combo Panel Type 43,Panels, test, susceptibility, antimicrobial Catalog number B1017217see related information
Date Initiated by FirmMay 04, 2018
Create DateAugust 02, 2018
Recall Status1 Terminated 3 on August 07, 2020
Recall NumberZ-2599-2018
Recall Event ID 80330
510(K)NumberK020160 
Product Classification Panels, test, susceptibility, antimicrobial - Product Code LTT
ProductMicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
Code Information Lot 2018-11-03
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact
469-961-4941
Manufacturer Reason
for Recall		The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.
FDA Determined
Cause 2		Labeling design
ActionA recall notification letter was sent the week of 05/01/2018 via email, mail, and phone if needed.
Quantity in Commerce686 boxes
DistributionNJ, TX, IA, PA, FL, NE, OH, NY, CA, MO, OK, LA
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.
510(K) Database510(K)s with Product Code = LTT
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