Stanbio Laboratory, LP
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Stanbio Laboratory, LP and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-12-13FDA-DeviceClass IISTAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
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.
Get notified about new Stanbio Laboratory, LP recalls
Free weekly digest. We email when a new federal recall affects Stanbio Laboratory, LP or anything else in your household.
Get the Sunday Brief