Recall Z-2391-2018— Ekla Corporation

Name: FDA recall Z-2391-2018
Creator: U.S. Food and Drug Administration
Published: 2016-10-20

Class II · Terminated

Class II FDA medical device recall by Ekla Corporation, initiated 2016-10-20, terminated 2023-11-29. It names one FDA 510(k) clearance: K112101. Product: NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test. Reason: Incorrect hCG results.

Recalling firm: Ekla Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-10-20
Terminated: 2023-11-29
Firm location: Naperville, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTSPolymed Therapeutics, Inc.·cleared 2012-07-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test

Reason for recall

Incorrect hCG results

Data sourced from openFDA. This site is unofficial and independent of the FDA.