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U.S. Department of Health and Human Services

Class 2 Device Recall Vital Diagnostics Envoy Calcium Reagent For InVitro Diagnostic Use

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  Class 2 Device Recall Vital Diagnostics Envoy Calcium Reagent For InVitro Diagnostic Use see related information
Date Initiated by Firm August 29, 2013
Date Posted January 14, 2014
Recall Status1 Terminated 3 on August 26, 2015
Recall Number Z-0732-2014
Recall Event ID 66202
510(K)Number K120626  
Product Classification Azo dye, calcium - Product Code CJY
Product Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use.
PN 55285
For the quantitative measurement of calcium in plasma and serum
Code Information All lots
Recalling Firm/
Manufacturer		 Vital Diagnostics, Inc.
27 Wellington Rd
Lincoln RI 02865-4411
For Additional Information Contact SAME
401-642-8400
Manufacturer Reason
for Recall		 High positive calcium bias on plasma sample versus results on serum
FDA Determined
Cause 2		 Device Design
Action Vital Diagnostics issued a Recall Notice dated August 29, 2013, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use plasma for the determination of total calcium when using the affected product. The use of serum is acceptable, thus the product can still be used to determine total calcium with this sample type. Vital Diagnostics released a corection to the package insert for the Envoy Calcium Reagent. Customers with the affected product in their laboratory, were instructed to discard the insert packed with the product and replace it with the insert enclosed with this bulletin. If product was transferred to another location, the bulletin should be forwarded to that location. The package insert was revised indicating to only use Serum samples when running Calcium. Vital Diagnostics issued a revised (expanded) notice dated September 19, 2013, to include the Consult Diagnostics¿ Eon Calcium Reagent (PN: 1429) requesting users to discontinue using the single vial Eon Calcium kit (PN: 1429). Customers with questions were instructed to call Vital Diagnostics Technical Support at 1-855-354-8324.. For questions regarding this recall call 401-642-8400.
Quantity in Commerce 395 units
Distribution 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 = CJY and Original Applicant = VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
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