ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent… — Class II medical device recall Z-1629-2018
Terminated recall by Abbott Gmbh & Co. KG, reported 2018-05-16, distributed in AL, AZ, CA, CO, CT, FL, GA, IL…. Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to
| Recall number | Z-1629-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Gmbh & Co. KG, Wiesbaden, N/A, Germany |
| Recall initiated | 2017-12-14 |
| Classified | 2018-05-04 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2018-10-10 |
| Distributed | 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 |
| Countries outside the US | AE, AR, AT, AU, BB, BD, BE, BG, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DZ, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, KE, KW, LB, LK, LT, LU, LV, MA, MX, MY, NG, NL, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SG, SI, SK, TH, TN, TR, TW, UY, ZA |
| Quantity | 10,153 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00380740017446, 00380740017453 |
| Lot numbers | 00517F000, 01117A000, 01216K000, 01217A000, 01316K000, 02217C000, 02217D000, 02317D000, 02417D000, 02817H000, 04117H000 |
| Expiration dates | 2018-02-04, 2018-04-13, 2018-06-17, 2018-06-24, 2018-09-02, 2018-10-21, 2018-11-25 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1629-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.