—#191732

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.

FDA product code: LIQ — Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K971585
Affected lot / code info: Lot numbers 750030M481, Exp. 4/29/2022; 750030N482, Exp. 12/2/2022; and 750030N483, Exp. 5/17/2023.

Why it was recalled

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

Root cause (FDA determination)

Storage

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

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

Timeline

Recall initiated: 2022-01-25
Terminated: 2023-01-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191732. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.