FDA Device recall Z-0328-2016
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to va…
- FDA Device
- Class III
- terminated
- Published 2015-12-02
On 2015-12-02 the FDA classified a Class III recall of CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to va… by Biochemical Diagnostics, citing CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0328-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-09-14 |
| Published | 2015-12-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biochemical Diagnostics |
| Distribution | US |
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
CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.
Identifiers
| code_info | Lot/Codes: KN165 (exp. 2017-09), KN169 (exp. 2017-10), KN171 (exp. 2017-11) and KN177 (exp. 2018-02) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0328-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.