Official recall record
Xpert® Xpress Strep A
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2023-11-24
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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