ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.
Check against the official notice below — it lists the full affected range.
Abbott Laboratories is recalling 5,483 units of ARCHITECT BNP Calibrators used to calibrate ARCHITECT iSystem equipment for B-type natriuretic peptide testing. The recalled calibrators were distributed nationwide across all U.S. states and to numerous countries worldwide. The recall was issued because the calibrators exhibit a time-dependent stability drift that causes patient and control test results from ARCHITECT BNP testing to become inaccurate over time.
The affected products include multiple lot numbers across three list numbers (8K2802, 8K2803, and 8K2809), with expiration dates ranging from July 2019 through January 2020. The recall notice does not specify a remedy or recommended course of action for consumers who may possess these products.
Written by software from the official notice below. Not reviewed by a lawyer.
Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
Reason for recall: Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. Distribution: Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed worldwide to ALGERIA, ANDORRA, AUSTRIA, AZERBAIJAN, BANGLADESH, BELARUS, BELGIUM, BOSNIA AND HERZEGOVI, BRUNEI, BULGARIA, CANADA, CAYMAN ISL Quantity: 5,483 units Lot/code info: a. List Number 8K2802 - Lot Number (Expiration Date) UDI: 44K79318 (23JUL2019) (01)00380740017460(17)190723(10)44K79318, 44K80818 (05SEP2019) (01)00380740017460(17)190905(10)44K80818, 44K82118 (09OCT2019) (01)00380740017460(17)191009(10)44K82118, 44K82618 (15NOV2019) (01)00380740017460(17)191115(10)44K82618, 44K85119 (22JAN2020) (01)00380740017460(17)200122(10)44K85119; b. List Number 8K2803 - Lot Number (Expiration Date) UDI: 44K79418 (23Jul2019) (01)00380740145255(17)190723(10)44K79418, 44K81018 (5Sep2019) (01)00380740145255(17)190905(10)44K81018, 44K82018 (9Oct2019) (01)00380740145255(17)191009(10)44K82018, 44K85219 (22Jan2020) (01)00380740145255(17)200122(10)44K85219; c. List Number 8K2809, Lot Number 44K84119, Expiration Date 17Dec2019, No UDI
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.