Z-0328-2016Class III

CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics...

Name: Z-0328-2016 CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics...
Creator: Biochemical Diagnostics Inc
Published: 2015-09-14
License: https://open.fda.gov/license/

Biochemical Diagnostics Inc / initiated 2015-09-14 / Terminated / root cause: labeling and UDI

FDA source

Biochemical Diagnostics Inc began a recall of CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the... on 2015-09-14. FDA classified it as Class III and gives the reason as "CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0328-2016
Classification: Class III
Status: Terminated
Initiated: 2015-09-14
Posted: 2015-11-23
Terminated: 2016-01-26
Recalling firm: Biochemical Diagnostics Inc
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.
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Biochemical Diagnostics sent a Notice of Correction Letter (dated August 26, 2015) to customers via USPS 1st class mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return the verification form, per the notification. For questions contact Alere Technical Service at 866-216-0094 or by email at verifications.at [email protected].
Quantity in commerce: Domestic: 4,473 kits
Distribution: US Nationwide Distribution
Product codes and lots: Lot/Codes: KN165 (exp. 2017-09), KN169 (exp. 2017-10), KN171 (exp. 2017-11) and KN177 (exp. 2018-02)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0328-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0328-2016	Class III	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-23

Product code JJX

K050328Class IPregnancy-SkreenBiochemical Diagnostic, Inc. / cleared 2005-03-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)