Recall Z-0490-2024— Stanbio Laboratory, LP
Class II · Ongoing
Class II FDA medical device recall by Stanbio Laboratory, LP, initiated 2023-10-02. FDA's recall record names no specific 510(k) clearance for this event. Product: STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.. Reason: 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..
- Recalling firm
- Stanbio Laboratory, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-02
- Firm location
- Boerne, TX, United States
Product description
STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.