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U.S. Department of Health and Human Services

Class 2 Device Recall CATSCREEN, RAPID TEST FOR MORAXELL

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  Class 2 Device Recall CATSCREEN, RAPID TEST FOR MORAXELL see related information
Date Initiated by Firm December 01, 2021
Create Date February 02, 2022
Recall Status1 Terminated 3 on January 09, 2023
Recall Number Z-0554-2022
Recall Event ID 89151
510(K)Number K960996  
Product Classification Discs, strips and reagents, microorganism differentiation - Product Code JTO
Product HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Code Information Model Number HADZ110, all lots
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
866-359-1704
Manufacturer Reason
for Recall		 Product stored incorrectly in temperature controlled setting instead of refrigeration.
FDA Determined
Cause 2		 Process control
Action Medline notified consignees on 12/01/2021, via first class mail letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock for affected product, quarantine any affected product on hand, complete and return the response form indicating product destroyed, and notify customers if the product was further distributed.
Quantity in Commerce 100 units (4 packs, 25 per pack)
Distribution US Nationwide distribution in the state of California.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JTO and Original Applicant = HARDY DIAGNOSTICS
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