SARS-CoV-2 Antigen Test
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Qiagen Sciences LLC
- Reason for Recall:
- QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SARS-CoV-2 Antigen Test
Product Codes/Lot Numbers:
GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659.
Distribution:
Distributed in: AZ, CA, DC, CO, FL, HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0941-2021
Related Recalls
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Qiagen Sciences
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt_name_Bacteria (Gram+) or rY'east_Enzymatic Lysis_ V2) which could potentially cause delayed or erroneous results depending on the downstream assay.
Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost