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ESSENTIAL PACKAGE SAMPLE COLLECTION KIT (USA)
RANDOX LABORATORIES LIMITED · Model SCK10684 · UDI-DI 05055273219951
PQD
Prescription
0
510(k) clearances
19
Adverse events
1
Recalls
53
Facilities
Description
The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebotomist. The samples will be transported to a professional laboratory for testing.
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.