FDA recall Z-1572-2023

Product

BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

Reason for recall

APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.

Distribution

US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, HI, IL, IN, KS, KY, LA, MI, MO, NC, ND, NE, NJ, NM, NY, OH, OK, PR,SC, TN, TX, UT, VT.

Key facts

Status

Ongoing

Initiation date

2023-02-28

Report date

2023-05-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Redmond, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1572-2023