Class III — Biochemical Diagnostics Inc
| Recalling firm | BIOCHEMICAL DIAGNOSTICS, INC. |
|---|---|
| Registered facility | BIOCHEMICAL DIAGNOSTICS, INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert. |
| Product | 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 |
| Distribution | US Nationwide Distribution |
| Initiated | 2015-09-14 |
| Classified | 2015-11-23 |
| Terminated | 2016-01-26 |
| Recall number | Z-0328-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Biochemical Diagnostics Inc (Z-0328-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72197/
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