Leica HistoCore PEGASUS Tissue Processor recall
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Why was Leica HistoCore PEGASUS Tissue Processor recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All devices with serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782; UDI-DI 04049188216397.
- Product
- Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Quantity
- 141 devices
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NV, NY, OH, TN, TX, UT, VA, WA, and WI. There was also government distribution but no military distribution. The country of Canada.
- Recall date
- June 12, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)