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

Recalled November 8, 2023 · FDA recall Z-0216-2024 · Cepheid

Hazard

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. · FDA Class II

Units

1,413 kits ( 10 test per kit)

Sold at

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

Description

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.

Product

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

Manufacturer(s)

Cepheid

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →