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.
Check against the official notice below — it lists the full affected range.
Abbott Gmbh & Co. KG is recalling the ARCHITECT DHEA-S Reagent, a test used to measure dehydroepiandrosterone sulfate levels in blood samples. The reagent may produce falsely elevated results when used with samples from infants up to 60 days old. A total of 10,153 units have been distributed worldwide, including throughout multiple U.S. states and internationally. The affected products are identified by List Nos. 8K2-20 and 8K27-25, with specific lot numbers and expiration dates ranging from February 2018 through October 2018.
The recall affects healthcare facilities and laboratories that received these specific lots of the ARCHITECT DHEA-S Reagent. Healthcare providers who used this product with infant samples during the affected time period should be aware that test results may have been inaccurately elevated. The source record does not specify what action affected consumers or healthcare facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.
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. 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, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cr Quantity: 10,153 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.