QuickVue Dipstick Strep A Test Recalled - False Positive Results
Summary
Health Canada issued a Type II medical device recall for the QuickVue Dipstick Strep A Test (catalog 20125) manufactured by Quidel Corporation due to false positive results. Affected lots include 709509, 709487, 709503, 709684, and 233275. False positives may include faint pink lines as well as pink-to-red test lines. Healthcare providers using these tests should stop using affected lots and contact the manufacturer.
What changed
Health Canada issued a Type II medical device recall for the QuickVue Dipstick Strep A Test due to complaints of false positive results from customers. The affected product lots are 709509, 709487, 709503, 709684, and 233275 (catalog number 20125), manufactured by Quidel Corporation. False positives may present as faint pink lines or pink-to-red test lines. The recall commenced on June 25, 2025.
Healthcare providers and laboratories using this diagnostic test must immediately identify and stop using the affected lots. They should contact Quidel Corporation directly to obtain replacement tests and verify whether any patient results may have been affected by false positive readings. Continued use of affected lots could lead to incorrect diagnoses and inappropriate treatment of patients.
What to do next
- Stop using affected product lots 709509, 709487, 709503, 709684, and 233275
- Contact Quidel Corporation for replacement tests and additional information
- Report any health or safety concerns to Health Canada
Archived snapshot
Apr 11, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
QuickVue® Dipstick Strep A Test
Brand(s)
Last updated
2026-04-10
Summary
Product QuickVue® Dipstick Strep A Test Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.
Audience Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| QuickVue® Dipstick Strep A Test | 709509 | 20125 |
| QuickVue® Dipstick Strep A Test | 709487 | 20125 |
| QuickVue® Dipstick Strep A Test | 709503 | 20125 |
| QuickVue® Dipstick Strep A Test | 709684 | 20125 |
| QuickVue® Dipstick Strep A Test | 233275 | 20125 |
Issue
QuidelOrtho™ received complaints regarding false positive results from customers testing with the QuickVue® Dipstick Strep A Test. False positives may include faint pink lines as well as pink-to-red test lines.
Recall start date: June 25, 2025
Additional information
Details
Original published date:
2025-07-03
Alert / recall type Health product recall Category Health products - Medical devices - Microbiology Companies Quidel Corporation
10165 Mckellar Court, San Diego, California, United States, 92121
Published by Health Canada Audience Healthcare Recall class Type II Identification number RA-77667
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