FDA recall Z-1641-2022

Product

T-SPOT.TB REF TB.300 US

Reason for recall

Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.

Distribution

U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None

Key facts

Status

Ongoing

Initiation date

2022-07-07

Report date

2022-09-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Abingdon, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1641-2022