Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Remel Haemophilus Test Medium

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Remel Haemophilus Test Medium see related information
Date Initiated by Firm March 10, 2021
Create Date April 13, 2021
Recall Status1 Open3, Classified
Recall Number Z-1425-2021
Recall Event ID 87495
510(K)Number K892928  
Product Classification Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
Product Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503

Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
Code Information Lot Numbers: Lot 220711 Exp. 2021-2-17
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Technical Services
800-255-6730
Manufacturer Reason
for Recall		 When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, ThermoFisher Scientific, sent an "Medical Device Field Action Recall" letter dated 3/10/2021 to its consignees on 03/10/2021. The letter described the product, problem and actions to be taken. The consignees were instructed to do the following: Review the reported test results should be determined by the appropriate technical expert. Please keep this notification on file. This notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have any questions, please contact Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com. You should complete the accompany Acknowledgment Form upon receipt and return to MBD.vigilance@thermofisher.com. If you have any further questions, contact Director, Quality Assurance and Regulatory Affairs at 913-895-4077 or email: gary.klaassen@thermofisher.com Copy to: Beverly Marsh - beverly.marsh@thermofisher.com.
Quantity in Commerce 19 units
Distribution US Nationwide distribution.
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 = JSO and Original Applicant = REMEL CO.
-
-