FDA Recall Terminated

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.

Recall: Z-0678-2022 · Initiated January 25, 2022

Recall

Recall Number: Z-0678-2022
Event Number: 89493
Firm: MEDLINE INDUSTRIES, LP Northfield
FEI Number: 1417592
Product Code: LIQ
Status: Terminated
Root Cause: Storage
Initiated: January 25, 2022
Terminated: January 9, 2023
Address: 3 Lakes Dr, Northfield, IL, 60093-2753

Description

Reason

The product was incorrectly shipped at room temperature rather than refrigerated.

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.

Distribution

US Distribution was made to IL, FL, LA, MS, NC, OH, and TX.

Quantity

19 kits