Terminated

Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.

FDA Recall Z-1991-2019 · Posted None

Recalling FirmAbbott Laboratories, Inc

Recall StatusTerminated

Product CodeDER

Date Initiated2018-05-16

Date Terminated2021-08-16

Product Quantity2,112 kits

Reason for Recall

An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

Firm Action

The recalling firm issued letters dated 5/16/2019 via FedEx priority overnight express on 5/16/2019 to the U.S. customers. For OUS, each country organization needs to establish their own method of notification, which normally consists of mailings or customer visits.

Root Cause

Under Investigation by firm

Distribution Pattern

Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Greenland, Honduras, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya. Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, Tunisia, UAE, United Kingdom, Uruguay, and Viet Nam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983289APOLIPOPROTEIN A1Abbott Laboratories · 1999-01-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.