Recall Z-1947-2024 ยท IEO Processor, Tissue, Automated
LEICA BIOSYSTEMS NUSSLOCH GMBH
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
| Date | Jun 4, 2024 (initiated Apr 10, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | The recalling firm issued letters to the Canadian consignees on 4/10/2024 via email and to the U.S. consignees on 4/18/2024 via email. The letter explained the reason for recall, the impact of the issue, and advice on immediate actions to be taken. The actions were: (1) Check reagent status in reagent bottles and paraffin status in paraffin bath. In case of any signs of contamination (such as muddiness, turbidity, or liquid separation) are observed, you should stop using the instrument for tissue processing and call for service. When no cross-contamination is observed, continue with the f |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.