FDA recall Z-0216-2024

Product

Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,

Reason for recall

pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.

Distribution

Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates.

Key facts

Status

Ongoing

Initiation date

2023-04-24

Report date

2023-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0216-2024