FDA recall Z-1941-2021

Product

OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326

Reason for recall

Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

Distribution

US Nationwide distribution in the states of FL, GA, SC.

Key facts

Status

Ongoing

Initiation date

2021-03-16

Report date

2021-06-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1941-2021