STAT-Site M BHB Test Strips — Class II medical device recall Z-0490-2024
Ongoing recall by Stanbio Laboratory, LP, reported 2023-12-13, distributed nationwide. Deterioration in the stability of the Test Strips results in diminished low-range detection capability and ina
| Recall number | Z-0490-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stanbio Laboratory, LP, Boerne, TX, United States |
| Recall initiated | 2023-10-02 |
| Classified | 2023-12-06 |
| Reported by FDA | 2023-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, SG |
| Quantity | 2,351 |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00657498000090 |
| Lot numbers | 203044, 209644 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0490-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.