FDA recall Z-0742-2022

Product

VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.

Reason for recall

Invalid calibrations (out of range high) while using the product.

Distribution

Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution.

Key facts

Status

Terminated

Initiation date

2022-02-09

Report date

2022-10-05

Termination date

2026-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0742-2022