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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT SHBG

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  Class 2 Device Recall ARCHITECT SHBG see related information
Date Initiated by Firm April 18, 2017
Date Posted May 03, 2017
Recall Status1 Terminated 3 on June 03, 2019
Recall Number Z-2613-2017
Recall Event ID 77070
510(K)Number K060818  
Product Classification Radioimmunoassay, testosterones and dihydrotestosterone - Product Code CDZ
Product ARCHITECT SHBG Reagent

The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.
Code Information List number: 8K26-20, Lot Numbers: 01916E000, 00316F000, 01816G000, 00916I000, 07316I000, 00916L000 ;   List Number: 8K26-25, Lot Numbers: 01816E000, 00216F000, 01716G000, 00816I000, 07216I000
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact
877-422-2688
Manufacturer Reason
for Recall		 Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Abbott sent an Product Correction ( Immediate Action Required ) letter dated April 18, 2017, to all affected customers (with a response form) shipped via FedEx. Customers were instructed to discontinue use of the Potassium EDTA specimen tube type with the assay. All impacted US consignees were requested to return a customer reply form acknowledging that all the necessary actions, letter, were understood and completed. All impacted distributors were required to provide signed attestation ensuring that all their affected customers were sent the product correction letter informing them of this issue. Remaining inventory, at the firm's distribution centers, will have labeling corrected by inserting a kit stuffer informing customers that Potassium EDTA specimen tube type should not be used and providing customers will the recommend specimen types. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 1(877) - 4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
Quantity in Commerce 7981 kits
Distribution Worldwide Distribution - USA (nationwide) and to the countries of : ARGENTINA, ARMENIA, AUSTRIA, AZERBAIJAN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BRUNEI, CANADA, CHINA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DEM. REP. OF THE CON, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, HUNGARY, INDIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MONTENEGRO, NAMIBIA, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VIETNAM
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 = CDZ and Original Applicant = BIOKIT S.A.
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