Abbott Laboratories, Inc: Medical Device Recall in 2019 - (Recall #: Z-1990-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin M in the sample.

Product Classification:

Class II

Date Initiated: May 16, 2018

Date Posted: July 31, 2019

Recall Number: Z-1990-2019

Event ID: 83189

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.

Status: Terminated

Product Quantity: 9,586 kits

Code Information:

All IFU's

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.

Voluntary or Mandated:

Voluntary: Firm initiated