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
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