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Pockit Hsv 2 Rapid Test

by Diagnology, Ltd. 510(k)

Active United States Open recall

510(k) K983886

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 NumberK983886 Date19 Aug 1999ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1021-2023 FDA Class II initiated 28 Sep 2022

    HSV-2 rapid test may report false positive results.

  • 2 recalls, same reason

    • Terminated Z-1970-2010 FDA Unclassified (pre-2012) initiated 14 Apr 2010
    • Terminated Z-1971-2010 FDA Unclassified (pre-2012) initiated 14 Apr 2010

    Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made.

Specification

510(k)

510(k) Number
FDA Product Code
LGC
FDA applicant
Diagnology , Ltd.
Device Class
Class II
Regulation
21 CFR Part 866.3305
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent