FDA recall Z-1421-2020

Product

Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143

Reason for recall

Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.

Distribution

Domestic distribution nationwide. Worldwide foreign distribution.

Key facts

Status

Ongoing

Initiation date

2020-01-12

Report date

2020-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1421-2020