Z-2613-2017Class II

ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for...

Name: Z-2613-2017 ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for...
Creator: Abbott Laboratories
Published: 2017-04-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-04-18 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone... on 2017-04-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2613-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-18
Posted: 2017-05-03
Terminated: 2019-06-03
Recalling firm: Abbott Medical
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.
Product code: CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: List number: 8K26-20, Lot Numbers: 01916E000, 00316F000, 01816G000, 00916I000, 07316I000, 00916L000 ; List Number: 8K26-25, Lot Numbers: 01816E000, 00216F000, 01716G000, 00816I000, 07216I000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2613-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2613-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-19

Product code CDZ

K060818Class IArchitect Shbg Reagent Kit, Architect Shbg Calibrator Kit, and Architect Shbg Control Kit with Models, 8K26-25, 8K26-01Biokit, S.A. / cleared 2007-01-23

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)