Abbott Laboratories: ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iS

Is my product affected?

ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic pe

• UPC 00380740017477
• UPC 00380740145262

Check against the official notice below — it lists the full affected range.

What happened

Abbott Laboratories recalled 6,623 units of ARCHITECT BNP Controls used to test precision and detect analytical deviations in ARCHITECT iS testing systems. The controls were found to have a time-dependent stability drift that affected patient and control results. The affected lots were distributed nationwide across all U.S. states and worldwide to numerous countries.

The recall document does not specify a remedy or instructions for what consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.

Details from the source

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: 6,623 units Lot/code info: a. List Number 8K28 11 - Lot Number (Expiration Date) UDI: 44K78918 (18JUN2019) (01)00380740017477(17)190618(10)44K78918, 44K80918 (05SEP2019) (01)00380740017477(17)190905(10)44K80918, 44K82718 (15NOV2019) (01)00380740017477(17)191115(10)44K82718; b. List Number 8K28 12 - Lot Number (Expiration Date) UDI: 44K79518 (23Jul2019) (01)00380740145262(17)190723(10)44K79518, 44K81118 (5Sep2019) (01)00380740145262(17)190905(10)44K81118, 44K82818 (15Nov2019) (01)00380740145262(17)191115(10)44K82818, 44K84219 (17Dec2019) (01)00380740145262(17)191217(10)44K84219

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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