Health product recall

Xpert® Xpress Strep A

Brand(s)
Last updated

Summary

Product
Xpert® Xpress Strep A
Issue
Medical devices - Performance issue
What to do

Contact manufacturer, dispose of affected product, and coordinate reception of replacements. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Xpert® Xpress Strep A Batch: 100613359, Lot: 23815 XPRSTREP A-CE-10

Issue

XPRSTREPA-CE-10 kits packaged with defective pipettes may cause failure to dispense an adequate volume of the patient sample to the test cartridge. If there is inadequate volume of patient sample being tested, the customer may receive an 'invalid' or 'no result' test results.

Recall start date: April 24, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Microbiology
Companies
Cepheid
904 Caribbean Drive, Sunnyvale, California, United States, 94089
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74638