🔍 RecallPedia

Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.

Class I - Dangerous
🏥 Medical Devices Recalled: March 7, 2017 PerkinElmer Life and Analytical Sciences, Wallac, OY Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Software Version: 1.3 Rev2, 1.7, 1.8, 1.9, 1.9 Rev2
  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:
PerkinElmer Life and Analytical Sciences, Wallac, OY
Reason for Recall:
Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.

Product Codes/Lot Numbers:

Software Version: 1.3 Rev2, 1.7, 1.8, 1.9, 1.9 Rev2

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1761-2017

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