Recall Z-1629-2018 ยท JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Abbott Gmbh & Co. KG
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.
| Date | Dec 14, 2017 |
| Status | Terminated |
| Reason | Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old. |
| Root cause | Device Design |
| Action | Customers were notified via letter on about 12/14/2017. Instructions included to immediately discontinue use of the ARCHITECH DHEA-S assay with samples form infants up to 60 days old, to immediately discontinue use of the ARCHITECH DHEA-S reagent insert Expected Values representative data for children up to 10 years old, to review the letter with the Medial Director and follow the laboratory protocol regarding the need for reviewing previously reported patient results, to forward the Product Correction letter to customers if the product was further distributed, and to complete and return the |
| Quantity | 10,153 units |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.