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RenalytixAI Urine Collection Kit
Renalytix Ai, Inc. · Model RENX3011003 · UDI-DI 00860009877917
OIE
Prescription
0
510(k) clearances
10
Adverse events
2
Recalls
47
Facilities
Description
Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory for uACR testing
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-09 | Medical Action Industries, Inc. 306 | An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027. |
| 2014-04-17 | Gen-Probe Inc | Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collect |
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