FDA recall Z-0180-2022

Product

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543

Reason for recall

The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.

Distribution

Worldwide distribution - US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2021-09-20

Report date

2021-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0180-2022