NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
FDA Recall Z-2391-2018 · Posted None
Recalling FirmEkla Corporation
Recall StatusTerminated
Product CodeJHI
Date Initiated2016-10-20
Date Terminated2023-11-29
Product Quantity295 kits
Reason for Recall
Incorrect hCG results
Firm Action
Emails were sent to Distributors and Medical Facilities on 09/21/2016. Follow up phone calls also were made.
Root Cause
Process control
Distribution Pattern
US National Distribution in the states of CA, IL, MN and RI
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.