Reported Dec 13, 2023 · Ongoing
STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
Stanbio Laboratory, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stanbio Laboratory, LP · 1261 N Main St · Boerne, TX · 78006-3014
Is this the product you have?
- STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
- Lot codes and dates
- UDI-DI00657498000090
- Lot/Expiration
203044/2024-01-31209644/2024-06-30
- Amount recalled
- 2,351
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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