Ovulation test devices recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 1,000 units of the LH One Step Ovulation Test Device (Urine) because tests requiring a 510(k) were distributed before they could be legally marketed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: the record states the devices may give false or inaccurate results leading to inappropriate medical intervention, and no injuries are reported.
Plain-English summary
This recall by Changchun Wancheng Bio-Electron Co., Ltd. covers the LH One Step Ovulation Test Device (Urine).
The record states that test strips and other tests, including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers, and that the devices may cause a false or inaccurate diagnostic result by a lay person and lead to inappropriate medical intervention.
The record lists 1,000 units, with the lot number and expiration date recorded in the enforcement record. The record gives distribution as US nationwide in the states of Texas, Georgia and California. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Consumers should follow the seller's return instructions and speak to a clinician rather than relying on a result from an affected test.
The recalled product
- Product
- LH One Step Ovulation Test Device (Urine)
- Manufacturer
- Changchun Wancheng Bio-Electron Co., Ltd.
- Category
- Medical Device — Diagnostic test
- Affected units
- 1,000
Distribution
Part of a larger recall action
This product is one of 11 recalled by Changchun Wancheng Bio-Electron Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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