Urinalysis test strips recalled over missing FDA premarket clearance

Plain-English summary

LotFancy Urinary Tract Infection Urine (UTI) Test Strips, PALINOIA UTI-10 Parameter Reagent Strips, Vaunn Medical 8-in-1 Urinalysis Reagent Strip, JNW Direct 4-in-1 UTI Urinalysis Test Strips and Urinify Strength, Essential and Urine test strips, among the products listed in the enforcement record is being recalled by Changchun Wancheng Bio-Electron Co., Ltd.

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 91,366 units, with product names, lot numbers and expiration dates 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

LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)

Manufacturer

Changchun Wancheng Bio-Electron Co., Ltd.

Category

Medical Device — Test strip

Hazard

• premarket-clearance
• false-results
• near-patient-testing

Affected units

91,366

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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