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U.S. Department of Health and Human Services

Class 3 Device Recall CONSULT(TM) hCG CONTROLS Kit

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  Class 3 Device Recall CONSULT(TM) hCG CONTROLS Kit see related information
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
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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