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…
Read the official notice →- Date
- 2024-02-21
- Country
- United States
- Brand
- Quidel
- Product
- The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of FL, TN, IL, LA, NY, IN.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
US
Quidel 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 →- 2025-09-17
US
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.
FDA · DeviceQuidel CorporationWorldwide - US Nationwide distribution in the states of MA, NJ, MD, NC, SC,…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 →- 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
- 2024-02-21
US
BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD…
Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
FDA · DeviceBioFire Diagnostics, LLCWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice →US
CooperSurgical, Inc. recalls global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human…
The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.
FDA · DeviceCooperSurgical, Inc.Worldwide - US Nationwide including in the states of AL, AZ, CA, CO, FL, GA,…Official notice →US
PHILIPS MEDICAL SYSTEMS recalls CombiDiagnost R90 1.1 (709031)
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image…
FDA · DevicePHILIPS MEDICAL SYSTEMSUS Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME,…Official notice →US
Stryker, Inc. recalls Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
FDA · DeviceStryker, Inc.US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH,…Official notice →US
SEDECAL SA recalls MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine…
FDA · DeviceSEDECAL SAUS Nationwide distribution. There was government distribution but no military…Official notice →US
Zimmer Surgical Inc recalls 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage or additional unplanned graft if deemed necessary.
FDA · DeviceZimmer Surgical IncWorldwide - US Nationwide distribution including in the states of CA, DE, FL,…Official notice →