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IBSchek

COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC. · Model IVD-1-Chek · UDI-DI 00856820008005

PQD
0
510(k) clearances
19
Adverse events
1
Recalls
53
Facilities

Description

Capillary blood collection convenience kit

Recalls

DateFirmReason
2022-03-16LetsGetChecked Inc.Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sa

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.