CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

Architect Dhea-s Reagent recalled by Abbott Gmbh & Co. KG

Abbott Gmbh & Co. KG is recalling Architect Dhea-s Reagent, distributed in 31 states. The recall was initiated on 14 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesList 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

Quantity recalled10,153 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1629-2018
FDA event ID: 79482
Recalling firm: Abbott Gmbh & Co. KG, Wiesbaden, N/A
Classification: Class II
Status: Terminated
Recall initiated: 14 Dec 2017
FDA classified: 4 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

14 Dec 2017	Recall initiated by company
4 May 2018	Classified by FDA	+141 days
16 May 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

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 .

Alabama Arizona California Colorado Connecticut Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Massachusetts Minnesota Missouri Mississippi North Carolina New Jersey New York Ohio

Questions about this recall

Why was it recalled?

Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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