Innovacon Hcg Uktra Test Device

510(k) K062361

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK062361	Date23 Oct 2006Cleared	StatusActive

5 recalls · 3 ongoing · FDA

- Ongoing Z-3271-2026 FDA Class II initiated 20 Aug 2026
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
2 recalls, same reason
- Ongoing Z-1587-2022 FDA Class II initiated 25 May 2022
- Ongoing Z-1606-2022 FDA Class II initiated 25 May 2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- Terminated Z-1401-2013 FDA Class II initiated 16 Apr 2013
The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere" hCG Combo Cassette (20/10 mIU/mL) PN 92215 kit lots were incorrectly packaged with the Alere" hCG Cassette (20 mIU/mL) PN 92210 Product Insert. The Alere" hCG Cassette (20 mIU/mL) Product Insert contains information for
- Terminated Z-1118-2008 FDA Unclassified (pre-2012) initiated 1 Oct 2007
Incorrect results: The Sure-Vue Serum/Urine hCG-STAT test, when interpreted at extended read times, may exhibit sensitivity to patient samples containing hCG at levels well below the cut-off, potentially resulting in a false positive interpretation by the user.

1 jurisdiction

United States — FDA 510(k) Active

510(k)