Recall Z-1629-2018— Abbott Gmbh & Co. KG
Class II · Terminated
Class II FDA medical device recall by Abbott Gmbh & Co. KG, initiated 2017-12-14, terminated 2018-10-10. FDA's recall record names no specific 510(k) clearance for this event. 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: Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old..
- Recalling firm
- Abbott Gmbh & Co. KG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-14
- Terminated
- 2018-10-10
- Firm location
- Wiesbaden, N/A, Germany
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.