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

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.

Details from the source

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. Quantity: 1,413 kits ( 10 test per kit) Lot/code info: UDI: (01)07332940006297/ Lot: 23815

UPC codes

07332940006297

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.