🔍 RecallPedia

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

Class I - Dangerous
🏥 Medical Devices Recalled: January 10, 2022 Remel Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Product Number MDRGN2F; Lots: 1) B1402A (Expiration 2022/Oct05) 2) B1315A (Expiration 2022/Aug06) 3) B1211 (Expiration 2022/May24) 4) B1161A (Expiration 2022/Apr19 5) B0361 (Expiration 2021/Aug31) 6) B0164B (Expiration 2021/Apr16)
  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:
There are lower than expected MICs for some gram negative species.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

Product Codes/Lot Numbers:

Product Number MDRGN2F; Lots: 1) B1402A (Expiration 2022/Oct05) 2) B1315A (Expiration 2022/Aug06) 3) B1211 (Expiration 2022/May24) 4) B1161A (Expiration 2022/Apr19 5) B0361 (Expiration 2021/Aug31) 6) B0164B (Expiration 2021/Apr16)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0722-2022

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