Cepheid: Medical Device Recall in 2023 - (Recall #: Z-0216-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 24, 2023

Date Posted: November 8, 2023

Recall Number: Z-0216-2024

Event ID: 93125

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.

Status: Ongoing

Product Quantity: 1,413 kits ( 10 test per kit)

Code Information:

UDI: (01)07332940006297/ Lot: 23815

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated