Blood Ketone Test Strips Recalled for False Negative Results
Stanbio Laboratory is recalling STAT-Site M BHB Test Strips due to stability deterioration that causes false negative results. This defect may delay diagnosis and treatment of patients with conditions such as diabetic ketoacidosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. However, the defect creates significant risk by producing false negative results that could delay critical diagnosis and treatment of patients with serious conditions such as diabetic ketoacidosis.
Plain-English summary
Stanbio Laboratory is recalling 2,351 units of STAT-Site M BHB Test Strips, which are used with the STAT-Site M Beta-HB Meter to measure blood ketone values. The strips are distributed nationwide in the US and also in Canada and Singapore.
The test strips are affected by stability deterioration caused by a pH shift in the coating solution during manufacturing. This instability reduces the strips' ability to detect low-range ketone values and causes them to fail to meet promised linearity performance specifications.
As a result of these defects, the test strips may produce false negative results—indicating lower or absent ketones when they are actually present. This can lead to delayed diagnosis and treatment initiation for patients with conditions such as diabetic ketoacidosis.
The recalled product
- Product
- STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
- Manufacturer
- Stanbio Laboratory, LP
- Hazard
- false-negatives
- test-inaccuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 00657498000090
- Lot/Expiration: 203044/2024-01-31
- 209644/2024-06-30
Distribution
Distributed nationwide across the United States.
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