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U.S. Department of Health and Human Services

Class 2 Device Recall meridian bioscience immunocard STAT!

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 Class 2 Device Recall meridian bioscience immunocard STAT!see related information
Date Initiated by FirmJanuary 25, 2022
Create DateFebruary 24, 2022
Recall Status1 Terminated 3 on January 09, 2023
Recall NumberZ-0678-2022
Recall Event ID 89493
510(K)NumberK971585 
Product Classification Enzyme linked immunoabsorbent assay, rotavirus - Product Code LIQ
Productmeridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
Code Information Lot numbers 750030M481, Exp. 4/29/2022; 750030N482, Exp. 12/2/2022; and 750030N483, Exp. 5/17/2023.
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactMs. Karin Johnson
866-359-1704
Manufacturer Reason
for Recall		The product was incorrectly shipped at room temperature rather than refrigerated.
FDA Determined
Cause 2		Storage
ActionThe recalling firm, Medline Industries, LP, issued "URGENT RECALL NOTIFICATION MEDLINE INDUSTRIES, INC. IMMEDIATE ACTION REQUIRED" letters dated 1/25/2022 via first class mail on 1/25/2022. The letters were flagged that immediate action was required and the product was identified and the reason for recall was explained. The required actions instructed the customer to: 1) immediately check their stock for the affected item number and lot numbers listed in the attachment. Quarantine all affected product. 2) The customer was to complete and return the response form after completion to indicate the amount of product they are destroying. Even if they do not have any affected product. 3) If the product has been transferred to another individual or location in their organization, they are to notify them of the recall. On 2/4/2022, an updated letter was issued via first class mail which removed lot 7869.391 as an affected lot number. The lot number was also removed on the Destruction Form. If you have any questions, please contact 866-359-1704.
Quantity in Commerce19 kits
DistributionUS Distribution was made to IL, FL, LA, MS, NC, OH, and TX.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LIQ
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