FDA recall Z-0884-2022

Product

Alinity m HBV AMP Kit (US and CE)

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2022-03-04

Report date

2022-04-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Des Plaines, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0884-2022