# FDA recall Z-1994-2019

> **Abbott Laboratories, Inc** · Class II · device recall initiated 2018-05-16.

## Product

Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of  apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine  with apolipoprotein B 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 604 nm, is directly proportional to the  concentration of apolipoprotein B in the sample.

## 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.

## Distribution

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, Singap

## Key facts

- **Recall number:** Z-1994-2019
- **Recalling firm:** Abbott Laboratories, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-16
- **Report date:** 2019-07-31
- **Termination date:** 2021-08-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1994-2019

## Citation

> AI Analytics. FDA recall Z-1994-2019. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1994-2019. Source: US FDA. Licensed CC0.

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