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LetsGetChecked Blood Sample Collection Kit (TRFN)
PRIVAPATH DIAGNOSTICS LIMITED · Model BO07S · UDI-DI 00810111410342
0
510(k) clearances
19
Adverse events
1
Recalls
54
Facilities
Description
A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-16 | LetsGetChecked 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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Get your free API keyRead the docsData 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.