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U.S. Department of Health and Human Services

Class 2 Device Recall Thermo Scientific

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  Class 2 Device Recall Thermo Scientific see related information
Date Initiated by Firm January 10, 2022
Create Date March 04, 2022
Recall Status1 Open3, Classified
Recall Number Z-0722-2022
Recall Event ID 89416
510(K)Number K193538  
Product Classification Manual antimicrobial susceptibility test systems - Product Code JWY
Product Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Code Information Product Number MDRGN2F; Lots: 1) B1402A (Expiration 2022/Oct05) 2) B1315A (Expiration 2022/Aug06) 3) B1211 (Expiration 2022/May24) 4) B1161A (Expiration 2022/Apr19 5) B0361 (Expiration 2021/Aug31) 6) B0164B (Expiration 2021/Apr16) 
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact
913-895-4077
Manufacturer Reason
for Recall		 There are lower than expected MICs for some gram negative species.
FDA Determined
Cause 2		 Under Investigation by firm
Action A customer letter was issued to impacted consignees on or around 01/10/2022. Customers are asked to check for affected product and the recalling firm requests that customers do not report results of cefiderocol when affected product is used with Thermo Scientific Mueller-Hinton Broth with TES, catalong T3462, lots 267261 to 402775. Consignees are asked to disseminate the recall information within their organization and to any other organization to which affected products have been transferred. An acknowledgement form should be submitted by email to MBD.vigilance@thermofisher.com.
Quantity in Commerce 1210 devices
Distribution Distribution throughout the United States.
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.
510(K) Database 510(K)s with Product Code = JWY and Original Applicant = Thermo Fisher Scientific
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