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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.

FDA Recall Z-0678-2022 · Posted None

Recall StatusTerminated
Product CodeLIQ
Date Initiated2022-01-25
Date Terminated2023-01-09
Product Quantity19 kits

Reason for Recall

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

Firm 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.

Root Cause

Storage

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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