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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect medical test results, which poses a risk of harm (misdiagnosis) even though specific injuries or illnesses are not reported in the source text.
Plain-English summary
Ekla Corporation is recalling 295 units of the NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS. The recall was initiated because the devices may produce incorrect hCG results.
The affected products are identified by Lot # F606032 with an expiration date of 2018-05. These kits were distributed nationally in the states of California, Illinois, Minnesota, and Rhode Island.
Consumers who possess these specific pregnancy test kits should stop using them and contact Ekla Corporation for further instructions or a refund.
The recalled product
- Product
- NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
- Manufacturer
- Ekla Corporation
- Category
- Medical Device — Pregnancy Test
- Hazard
- Affected units
- 295
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # F606032 (exp 2018-05)
Distribution
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