Home / Recalls / Abbott Laboratories / Z-2079-2019

Z-2079-2019 Class III Terminated

Recalled by Abbott Laboratories — Abbott Park, IL

Recall Details

Product Type
Devices
Report Date
July 31, 2019
Initiation Date
May 24, 2019
Termination Date
April 1, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,623 units

Product Description

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 peptide (BNP) in human EDTA plasma.

Reason for Recall

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

Distribution Pattern

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 ISLANDS, CHILE, CROATIA, CURACAO, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GAZA & JERICHO, GEORGIA, GERMANY, GREECE, GREENLAND, HONDURAS, HUNGARY, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, KUWAIT, KYRGYZSTAN, LEBANON, LITHUANIA, LUXEMBOURG, MACEDONIA, MALDIVES, MALI, MAURITANIA, MONTENEGRO, MOROCCO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TANZANIA, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UGANDA, UNITED KINGDOM, VIETNAM, ZIMBABWE.

Code Information

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

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