Official recall record

STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

US FDA — Medical Devices · 2023-10-02 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-10-02
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 00657498000090
Brand on record: Stanbio Laboratory, LP

What the authority reported

Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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