FDA recall Z-1286-2023

Product

CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826

Reason for recall

The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range

Distribution

PA, OH, WV

Key facts

Status

Ongoing

Initiation date

2023-02-01

Report date

2023-04-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kearneysville, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1286-2023