FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: 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 number
- Z-0678-2022
- 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.
- Status
- Terminated
- Initiated
- 2022-01-25
- Posted
- not on file
- Terminated
- 2023-01-09
- Reason
- The product was incorrectly shipped at room temperature rather than refrigerated.
- 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
- 19 kits
- Distribution
- US Distribution was made to IL, FL, LA, MS, NC, OH, and TX.
- Lot, serial or model codes
- Lot numbers 750030M481, Exp. 4/29/2022; 750030N482, Exp. 12/2/2022; and 750030N483, Exp. 5/17/2023.
- 510(k) numbers
- ["K971585"]
- PMA numbers
- not on file
- Product code
- LIQ
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28