FDA Device Intelligence
Home › Hearts Bio, Inc. › HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX)

HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX)

Hearts Bio, Inc. · Model TD-4289 · UDI-DI 00850014861353

LFQ
5
510(k) clearances
1
Adverse events
1
Recalls
3
Facilities

Recalls

DateFirmReason
2016-07-20Sterling Diagnostics, Inc.Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.