Recall Z-1446-2013 ยท IDZ Cassettes, Tissue
Leica Microsystems, Inc.
LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.
| Date | Jun 3, 2013 (initiated Apr 4, 2013) |
| Status | Terminated |
| Reason | An LPC Fine Mesh Cassette failed to stay closed during processing operations. |
| Root cause | Device Design |
| Action | A Medical Device Correction letter dated April 17, 2013 was sent to customers via USPS 1st class mail. The product issue was described and recommended actions were provided. Customers were requested to acknowledge receipt of the letter by fax-back. Customer questions were directed to (847) 405-5413. |
| Quantity | 20,160 units |
| Distribution | Worldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.