Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
CONSULT(TM) diagnostics hCG CONTROLS Kit Recalled by Biochemical Diagnostics Inc Due to CONSULT diagnostics hCG Controls have discrepant storage temperatures...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biochemical Diagnostics Inc directly.
Affected Products
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
Quantity: Domestic: 4,473 kits
Why Was This Recalled?
CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Biochemical Diagnostics Inc
Biochemical Diagnostics Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report