Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.
- 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:
- Abbott Molecular, Inc.
- Reason for Recall:
- Reports received of an increase of message code 9186 (internal control failed) when using the kit.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
Product Codes/Lot Numbers:
Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1679-2022
Related Recalls
There were reports of an increase in reactive negative controls and false positive results.
There were reports of an increase in reactive negative controls and false positive results.
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