FDADecember 14, 2017device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.
What to do
FDA enforcement status: Terminated
Brands named
abbott gmbh co kgabbottabbott gmbh
UPCs
0038074001744600380740017453
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMerlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software2026-05-12
- FDAPediatric care bed; Product Designation: KayserBett IDA;2026-05-04
- FDAi-STAT G3+ cartridge; List Number: 03P78-26;2026-04-01
- FDAi-STAT EG7+ cartridge; List Number: 03P76-25;2026-04-01
- FDAi-STAT EG6+ cartridge; List Number: 03P77-25;2026-04-01
- FDAHeraeus, PALAMIX duo. Material Number: 66057897.2026-03-25
- FDAHeraeus, PALAMIX uno. Material Number: 66057893.2026-03-25
- FDAEmbrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;2026-02-11
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