# FDA recall Z-1629-2018

> **Abbott Gmbh & Co. KG** · Class II · device recall initiated 2017-12-14.

## 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.

## 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.

## 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, Thai

## Key facts

- **Recall number:** Z-1629-2018
- **Recalling firm:** Abbott Gmbh & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-14
- **Report date:** 2018-05-16
- **Termination date:** 2018-10-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wiesbaden, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1629-2018

## Citation

> AI Analytics. FDA recall Z-1629-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1629-2018. Source: US FDA. Licensed CC0.

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