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Acon One Step Pregnancy Test Strip (Urine)

by Acon Laboratories, Inc. 510(k)

Active United States Open recall

510(k) K993203

Regulatory status

as of 29 Oct 2026

Recall ongoing. 2 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993203 Date1 Dec 1999ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-3273-2026 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.

    • 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-0706-03 FDA Unclassified (pre-2012) initiated 20 Feb 2003

    Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.

Specification

510(k)

510(k) Number
FDA Product Code
JHI
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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