FDA recall Z-2043-2023

Product

Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

Reason for recall

Reagent lot numbers include an insufficient concentration of blocking reagent.

Distribution

Distribution was made to CA, CO, CT, FL, GA, IL, IN, MA, MI, NC, NE, NJ, NY, OH, SC, TN, TX, UT, and WA. There was government distribution but no military distribution. Foreign distribution was made to Australia, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Korea, Lithuania, Macao, Mexico, Portugal, Russia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, and Vietnam.

Key facts

Status

Ongoing

Initiation date

2023-05-17

Report date

2023-07-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2043-2023