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RECALLS & FIELD CORRECTIONS—CLASS II

Visby Medical COVID-19 Test Kit

Biomedical Safety & Standards: April 01, 2021 - Volume 51 - Issue 6 - p 46
doi: 10.1097/01.BMSAS.0000737968.56612.c4
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Company: Visby Medical Inc, 3010 N 1st St, San Jose, CA 95134; Ph.: 833-468-4729.

Recall began: December 5, 2020.

Device(s): Visby Medical COVID-19 Test Kit (Recall # Z-0847-2021).

For codes:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=185131.

Quantity: 282.

Reason for recall: There are 2 issues: 1) 5 lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived; and 2) 3 lots contain a kit component that expires before the expiration date on the test kits.

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