Date Initiated by Firm |
September 14, 2015 |
Date Posted |
November 23, 2015 |
Recall Status1 |
Terminated 3 on January 26, 2016 |
Recall Number |
Z-0328-2016 |
Recall Event ID |
72197 |
510(K)Number |
K050328
|
Product Classification |
Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
|
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. |
Code Information |
Lot/Codes: KN165 (exp. 2017-09), KN169 (exp. 2017-10), KN171 (exp. 2017-11) and KN177 (exp. 2018-02) |
Recalling Firm/ Manufacturer |
Biochemical Diagnostics Inc 180 Heartland Blvd Edgewood NY 11717-8314
|
For Additional Information Contact |
Ms. Colleen Gang 631-595-9200
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 verifications.ts@alere.com. |
Quantity in Commerce |
Domestic: 4,473 kits |
Distribution |
US Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JJX and Original Applicant = BIOCHEMICAL DIAGNOSTIC, INC.
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