Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST

Class I - Dangerous
🏥 Medical Devices Recalled: October 20, 2022 Remel Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: B2125, B2115
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Remel Inc
Reason for Recall:
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST

Product Codes/Lot Numbers:

Lot Numbers: B2125, B2115

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0331-2023

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