Date Initiated by Firm |
March 10, 2021 |
Create Date |
April 13, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1424-2021 |
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 (150 mm) 10/PK, REF 04033
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: 201334 Exp. 2021-01-21, 210892 Exp. 2021-02-03, 217048 Exp. 2021-02-10 |
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 |
408 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.
|