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U.S. Department of Health and Human Services

Class 2 Device Recall ImmunoCard STAT! Crypto/Giardia Test Kits

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 Class 2 Device Recall ImmunoCard STAT! Crypto/Giardia Test Kitssee related information
Date Initiated by FirmMarch 24, 2025
Date PostedMay 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1719-2025
Recall Event ID 96662
510(K)NumberK983399 
Product Classification Giardia spp. - Product Code MHI
ProductMeridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Code Information UDI-DI: 00742860100017; Lot Number: 08241275
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer Reason
for Recall		A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn URGENT MEDICAL DEVICE RECALL notification letter dated 3/24/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3. Please destroy any affected inventory. Medline will issue credit for the product based upon the quantity and lot numbers identified on the submitted response form The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-25-063 Recall Code: Recall Code 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers return any affected product to you for collection and return to Medline Industries, LP. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce56 boxes
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MHI
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