Z-0678-2022Class II

meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT!...

Name: Z-0678-2022 meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT!...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-01-25
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-01-25 / Terminated

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative... on 2022-01-25. FDA classified it as Class II and gives the reason as "The product was incorrectly shipped at room temperature rather than refrigerated". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0678-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-25
Posted: 2022-02-24
Terminated: 2023-01-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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.
Product code: LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
Reason for recall: The product was incorrectly shipped at room temperature rather than refrigerated.
FDA root cause: Storage
Action: The 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 commerce: 19 kits
Distribution: US Distribution was made to IL, FL, LA, MS, NC, OH, and TX.
Product codes and lots: Lot numbers 750030M481, Exp. 4/29/2022; 750030N482, Exp. 12/2/2022; and 750030N483, Exp. 5/17/2023.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0678-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0678-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-24

Product code LIQ

K971585Class IImmunocard Stat! RotavirusMeridian Diagnostics, Inc. / cleared 1997-08-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)