Recall Z-0019-2019 ยท KIM Device For Sealing Microsections
Leica Microsystems, Inc.
Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
| Date | Sep 4, 2018 |
| Status | Terminated |
| Reason | Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock. |
| Root cause | Process design |
| Action | The firm issued a Field Action Notice by letter on 09/05/2018. The notice explained the issue and the possible hazard. The firm will schedule a visit with a service engineer to perform the correction. |
| Quantity | 1 unit |
| Distribution | Distribution in US state of MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.