Z-2078-2019 Class III Terminated
FDA device recall Z-2078-2019 was initiated by Abbott Laboratories on May 24, 2019 and is designated Class III. Reason for recall: Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. The recall status is terminated (terminated April 1, 2021). Affected quantity: 5,483 units.
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
- 5,483 units
Product Description
Reason for Recall
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.