Stanbio recalls STAT-Site M BHB Test Strips that may give false negative results, risking delayed treatment for diabetic ketoacidosis. Affected lots expire by 2024-01-31 and 2024-06-30.
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.
Stanbio is recalling STAT-Site M BHB Test Strips that can give false negative results, which might delay treatment for diabetic ketoacidosis. This is a serious risk for people using the strips to monitor blood ketones.
The test strips can deteriorate over time, causing false negative results. This means patients might not get treatment for diabetic ketoacidosis until it's too late, as the strips fail to detect low blood ketone levels.
People using STAT-Site M BHB Test Strips for blood ketone monitoring are affected. Those with diabetes who rely on these strips for detecting diabetic ketoacidosis are at highest risk.
Check the lot numbers on the strips: 203044 (expires 2024-01-31) or 209644 (expires 2024-06-30). The strips are used with the STAT-SITE M Beta-HB Meter for blood ketone testing.
Look for lot numbers 203044 (expires 2024-01-31) or 209644 (expires 2024-06-30) on the strips.
The test strips can deteriorate over time, causing false negative results that may delay treatment for diabetic ketoacidosis.
Check the lot numbers on the strips. If they match 203044 (expires 2024-01-31) or 209644 (expires 2024-06-30), stop using them and contact Stanbio for guidance.
No, the strips may give false negative results, which could delay treatment for diabetic ketoacidosis. Use only strips with valid lot numbers from the recall list.
We’ve drafted a message you can send Stanbio to request your refund or repair — edit it as you like.
Subject: Recall Z-0490-2024 — Stanbio Stanbio Hello, I own a Stanbio that is covered by recall Z-0490-2024 from Stanbio. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
