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.

Code information: List No. 8K2-20 with the following Lot No., Exp. Date, UDI: a. Lot No. 01316K000, Exp. Date 04FEB2018, UDI (01) 00380740017446 (17) 180204 (10) 01316K000 (240) 8K2720; b. Lot No. 01217A000, Exp. Date 13APR2018, UDI (01) 00380740017446 (17) 180413 (10) 01217A000 (240) 8K2720; c. Lot No. 02217D000, Exp. Date 24JUN2018, UDI (01) 00380740017446 (17) 180624 (10) 02217D000 (240) 8K2720; d. Lot No. 04117H000, Exp. Date 25NOV2018, UDI (01) 00380740017446 (17) 181125 (10) 04117H000 (240) 8K2720; List No. 8K27-25 with the following Lot No., Exp. Date, UDI: a. Lot No. 01216K000, Exp. Date 04FEB2018, UDI (01) 00380740017453 (17) 180204 (10) 01216K000 (240) 8K2725; b. Lot No. 01117A000, Exp. Date 13APR2018, UDI (01) 00380740017453 (17) 180413 (10) 01117A000 (240) 8K2725; c. Lot No. 02217C000, Exp. Date 17JUN2018, UDI (01) 00380740017453 (17) 180617 (10) 02217C000 (240) 8K2725; d. Lot No. 02317D000, Exp. Date 24JUN2018, UDI (01) 00380740017453 (17) 180624 (10) 02317D000 (240) 8K2725; e. Lot No. 02417D000, Exp. Date 24JUN2018, UDI (01) 00380740017453 (17) 180624 (10) 02417D000 (240) 8K2725; f. Lot No. 00517F000, Exp. Date 02SEP2018, UDI (01) 00380740017453 (17) 180902 (10) 00517F000 (240) 8K2725; g. Lot No. 02817H000, Exp. Date 21OCT2018, UDI (01) 00380740017453 (17) 181021 (10) 02817H000 (240) 8K2725

Distribution pattern: 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, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, Uganda, United Kingdom, Uruguay .