Biochemical Diagnostics Inc: Medical Device Recall in 2015 - (Recall #: Z-0328-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: September 14, 2015

Date Posted: December 2, 2015

Recall Number: Z-0328-2016

Event ID: 72197

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.

Status: Terminated

Product Quantity: Domestic: 4,473 kits

Code Information:

Lot/Codes: KN165 (exp. 2017-09), KN169 (exp. 2017-10), KN171 (exp. 2017-11) and KN177 (exp. 2018-02)

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated