Recall Z-2391-2018 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Ekla Corporation
NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
| Date | Oct 20, 2016 |
| Status | Terminated |
| Reason | Incorrect hCG results |
| Root cause | Process control |
| Action | Emails were sent to Distributors and Medical Facilities on 09/21/2016. Follow up phone calls also were made. |
| Quantity | 295 kits |
| Distribution | US National Distribution in the states of CA, IL, MN and RI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112101 | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS Polymed Therapeutics, Inc., Jul 17, 2012 |