Recall Z-0328-2016— Biochemical Diagnostics Inc

Name: FDA recall Z-0328-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-14

Class III · Terminated

Class III FDA medical device recall by Biochemical Diagnostics Inc, initiated 2015-09-14, terminated 2016-01-26. It names one FDA 510(k) clearance: K050328. 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..

Recalling firm: Biochemical Diagnostics Inc
Classification: Class III
Status: Terminated
Initiated: 2015-09-14
Terminated: 2016-01-26
Firm location: Edgewood, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K050328 — PREGNANCY-SKREENBiochemical Diagnostic, Inc.·cleared 2005-03-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.