The Recall Desk

Manufacturer

Ekla Corporation

1 recall in our database name Ekla Corporation as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2018-07-18

Of the 1 recalls from Ekla Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • HighFDA (Devices)·Z-2391-2018·2018-07-18

    Ekla Recalls NOVAPLUS Pregnancy Test Kits Due to Incorrect Results

    Ekla Corporation is recalling 295 NOVAPLUS Pregnancy Cassette Devices because they may provide incorrect hCG results. The affected kits were distributed in California, Illinois, Minnesota, and Rhode Island.

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