Stanbio Laboratory, LP: Medical Device Recall in 2023 - (Recall #: Z-0490-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 2, 2023

Date Posted: December 13, 2023

Recall Number: Z-0490-2024

Event ID: 93300

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.

Status: Ongoing

Product Quantity: 2,351

Code Information:

UDI-DI: 00657498000090, Lot/Expiration: 203044/2024-01-31, 209644/2024-06-30

Distribution Pattern:

Worldwide - US Nationwide distribution including in the states of AZ, RI, MO, UT, AK, LA, TX, OH, GA, MN, NY, CA, NJ, IL, WA, KS, MI, NC, PA, MA, CO, KY, NM, FL, MD, VA, IN, AL, SD, MS, WV, WI, ID, MT, WY and the countries of Canada and Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated