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Henry Schein 1022285Recalls & reported problems

Henry Schein, Inc. · Urispec 11-Way · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Apr 4, 2024Open, Classified

    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.

    Z-1834-2024 · Root cause: Under Investigation by firm · FDA record ↗

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.