Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Schein Inc. (HSI) customer complaint. This problem can potentially result in the possibility that the parameter leucocytes (a non-specific marker for urinary track infections and an indicator for inflammatory renal processes) is interpreted instrumentally as a false negative . The following HSI item number and lot number were affected: Urispec¿ 11-Way, #102-2285, LOT 65402.
What to do
FDA enforcement status: Ongoing
Brands named
UPCs
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPediatric care bed; Product Designation: KayserBett IDA;2026-05-04
- FDAHeraeus, PALAMIX uno. Material Number: 66057893.2026-03-25
- FDAHeraeus, PALAMIX duo. Material Number: 66057897.2026-03-25
- FDAEmbrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;2026-02-11
- FDAEmbrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;2026-02-11
- FDAEndo-Model Replacement Plateau; Item Number: 15-2835/12;2026-01-12
- FDAEndo-Model Replacement Plateau; Item Number: 15-2836/11;2026-01-12
- FDAEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;2026-01-12
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