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U.S. Department of Health and Human Services

Class 2 Device Recall Assayed quality control material for microbiology assays

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  Class 2 Device Recall Assayed quality control material for microbiology assays see related information
Date Initiated by Firm April 09, 2019
Create Date June 04, 2019
Recall Status1 Open3, Classified
Recall Number Z-1730-2019
Recall Event ID 82783
Product Classification Assayed external control material for microbiology nucleic acid amplification (NAT) assays - Product Code PMN
Product Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226

Product Usage:
On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.
Code Information Cepheid Xpert MRSA/MRSA NxG Control Panel  Catalog Number 8195 Lot Numbers: 8195-02, 8195-03, 8195-04, 8195-05, 8195-06, 8195-07, 8195-08, 8195-09, and 8195-10.  Cepheid Xpert¿ SA Nasal Complete Control Panel Catalog Number 8196 Lot Numbers: 8196-04, 8196-05, 8196-06, 8196-07, 8196-08 8196-09, 8196-10, and 8196-14. 
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information Contact Tina Sobania
320-253-1640
Manufacturer Reason
for Recall		 Product with incorrect shelf life.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.
Quantity in Commerce 249
Distribution Worldwide Distribution - US Nationwide AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, MI, MO,MS, MT, NC, ND, NJ, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, and WY. Australia, Chile, Germany, New Zealand, and United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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