Recall Z-0678-2022— MEDLINE INDUSTRIES, LP - Northfield
Class II · Terminated
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2022-01-25, terminated 2023-01-09. It names one FDA 510(k) clearance: K971585. 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.. Reason: The product was incorrectly shipped at room temperature rather than refrigerated..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-01-25
- Terminated
- 2023-01-09
- Firm location
- Northfield, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The product was incorrectly shipped at room temperature rather than refrigerated.
Data sourced from openFDA. This site is unofficial and independent of the FDA.