meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immun
Summary
The FDA issued a Class II for meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit bo by MEDLINE INDUSTRIES, LP - Northfield. Reason: The product was incorrectly shipped at room temperature rather than refrigerated..
Details
Source
Device Recall
External ID
Z-0678-2022
Action Date
2022-03-02
Status
Terminated
Category
device
Product Description
meridian 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.
Lot/Code Info: Lot numbers 750030M481, Exp. 4/29/2022; 750030N482, Exp. 12/2/2022; and 750030N483, Exp. 5/17/2023.
Quantity Affected: 19 kits
Reason for Recall
The product was incorrectly shipped at room temperature rather than refrigerated.
Distribution
US Distribution was made to IL, FL, LA, MS, NC, OH, and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-25
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0678-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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