Quidel Corporation recalls QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Dipstick strep A test has potential for false positive results.
Read the official notice →- Date
- 2025-09-17
- Country
- United States
- Brand
- Quidel
- Product
- QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of MA, NJ, MD, NC, SC,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Quidel recalls
- 2026-05-20
USQuidel Corporation recalls QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Product has the potential for false positive results
FDA · DeviceQuidel CorporationUS Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD,…Official notice →- 2024-05-01
- US
Quidel Corporation recalls QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may…
FDA · DeviceQuidel CorporationUS: AK AL AR AZ CA CO CT DC FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MT NC…Official notice → - 2024-02-21
- US
Quidel Corporation recalls The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect…
One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct…
FDA · DeviceQuidel CorporationUS Nationwide distribution in the states of FL, TN, IL, LA, NY, IN.Official notice → - 2023-04-05
- US
Quidel Corporation recalls MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037,…
Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
Other drugs & medical recalls in the United States
- 2025-09-17
- US
Quest International, Inc. recalls Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software…
Measles IgM Test Kit lacks premarket approval or clearance.
FDA · DeviceQuest International, Inc.US Nationwide distribution in the states of Utah, Texas, and Arizona.Official notice → - US
Boston Scientific Corporation recalls ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02,…
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
FDA · DeviceBoston Scientific CorporationWorldwide - US Nationwide and the countries of Canada, France, Germany and…Official notice → - US
Encore Medical, LP recalls Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product…
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL,…Official notice → - US
NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System
Replacement of the internal Sample Pump due to high failure rates.
- US
Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular, Software 8.0.0.4.
Software issue that results in the display of outdated information.
FDA · DevicePhilips Medical Systems Nederland B.V.US Nationwide distribution in the states of GA, NC & TX.Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →