CONSULT — Class III medical device recall Z-0328-2016
Terminated recall by Biochemical Diagnostics Inc, reported 2015-12-02, distributed nationwide. CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared w
| Recall number | Z-0328-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biochemical Diagnostics Inc, Edgewood, NY, United States |
| Recall initiated | 2015-09-14 |
| Classified | 2015-11-23 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2016-01-26 |
| Distributed | Nationwide (US) |
| Quantity | 4,473 kits |
| Reason classes | labeling |
| Lot numbers | KN165 |
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.
Reason for recall
CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.
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-0328-2016. 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.