Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    All devices with serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782; UDI-DI 04049188216397.
  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:
LEICA BIOSYSTEMS NUSSLOCH GMBH
Reason for Recall:
Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.

Product Codes/Lot Numbers:

All devices with serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782; UDI-DI 04049188216397.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1947-2024

Related Recalls

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Sep 4, 2024 Other Medical Devices Nationwide View Details →

As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.

Sep 4, 2024 Other Medical Devices Nationwide View Details →