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Acon Hcg One Step Pregnancy Test Device (Urine)

by Acon Laboratories, Inc. 510(k)

Active United States Open recall

510(k) K993317

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993317 Date1 Dec 1999ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-3274-2026 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.

    • Terminated Z-1344-2013 FDA Class III initiated 21 Jan 2013

    Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectly indicates the product may be used for both urine and serum sample types.

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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