Abbott Molecular, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0884-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Alinity m HBV AMP Kit (US and CE)

Product Classification:

Class II

Date Initiated: March 4, 2022

Date Posted: April 13, 2022

Recall Number: Z-0884-2022

Event ID: 89757

Reason for Recall:

There is a potential for misquantitation high results for negative samples.

Status: Ongoing

Product Quantity: 4966 kits, updated 101/17/2023

Code Information:

List Numbers: 1) 08N47-095 (US); Lots: 519756, 523799, and 524361, Updated to add: 381583, 529391, 529687, 530273, 531598; 2) 08N47-090 (CE); Lots: 519755, 520957, 522137, 523798, and 524059, Updated to add: 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596

Distribution Pattern:

US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated