Z-1629-2018Class II

ARCHITECT DHEA-S Reagent

Name: Z-1629-2018 ARCHITECT DHEA-S Reagent
Creator: Abbott Gmbh & Co. KG
Published: 2017-12-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-12-14 / Terminated / root cause: design

FDA source

Abbott Gmbh & Co. KG began a recall of ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone... on 2017-12-14. FDA classified it as Class II and gives the reason as "Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1629-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-14
Posted: 2018-05-04
Terminated: 2018-10-10
Recalling firm: Abbott Medical
Product: ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.
Product code: JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Reason for recall: Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.
Root cause tag: design
FDA root cause: Device Design
Action: Customers were notified via letter on about 12/14/2017. Instructions included to immediately discontinue use of the ARCHITECH DHEA-S assay with samples form infants up to 60 days old, to immediately discontinue use of the ARCHITECH DHEA-S reagent insert Expected Values representative data for children up to 10 years old, to review the letter with the Medial Director and follow the laboratory protocol regarding the need for reviewing previously reported patient results, to forward the Product Correction letter to customers if the product was further distributed, and to complete and return the Customer Reply Form. Questions from U.S. customers can be directed to Customer Service at 1-877-4ABBOTT (available 24 hours per day, 7 days a week) and customers outside the U.S. should contact their local area Customer Service.
Quantity in commerce: 10,153 units
Distribution: Worldwide Distribution in the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VT, WA, WY. Distributed internationally to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Egypt, Finland, France, Gaza and Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mexico, Morocco, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Tajikistan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, Uganda, United Kingdom, Uruguay .
Product codes and lots: List No. 8K2-20 with the following Lot No., Exp. Date, UDI: a. Lot No. 01316K000, Exp. Date 04FEB2018, UDI (01) 00380740017446 (17) 180204 (10) 01316K000 (240) 8K2720; b. Lot No. 01217A000, Exp. Date 13APR2018, UDI (01) 00380740017446 (17) 180413 (10) 01217A000 (240) 8K2720; c. Lot No. 02217D000, Exp. Date 24JUN2018, UDI (01) 00380740017446 (17) 180624 (10) 02217D000 (240) 8K2720; d. Lot No. 04117H000, Exp. Date 25NOV2018, UDI (01) 00380740017446 (17) 181125 (10) 04117H000 (240) 8K2720; List No. 8K27-25 with the following Lot No., Exp. Date, UDI: a. Lot No. 01216K000, Exp. Date 04FEB2018, UDI (01) 00380740017453 (17) 180204 (10) 01216K000 (240) 8K2725; b. Lot No. 01117A000, Exp. Date 13APR2018, UDI (01) 00380740017453 (17) 180413 (10) 01117A000 (240) 8K2725; c. Lot No. 02217C000, Exp. Date 17JUN2018, UDI (01) 00380740017453 (17) 180617 (10) 02217C000 (240) 8K2725; d. Lot No. 02317D000, Exp. Date 24JUN2018, UDI (01) 00380740017453 (17) 180624 (10) 02317D000 (240) 8K2725; e. Lot No. 02417D000, Exp. Date 24JUN2018, UDI (01) 00380740017453 (17) 180624 (10) 02417D000 (240) 8K2725; f. Lot No. 00517F000, Exp. Date 02SEP2018, UDI (01) 00380740017453 (17) 180902 (10) 00517F000 (240) 8K2725; g. Lot No. 02817H000, Exp. Date 21OCT2018, UDI (01) 00380740017453 (17) 181021 (10) 02817H000 (240) 8K2725

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1629-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1629-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code JKC

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)