Device product
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.
Z-1446-2013
Product summary
- Event
- Event 64968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,160 units
- Official record key
device-enforcement:Z-1446-2013
Official wording
Reason: An LPC Fine Mesh Cassette failed to stay closed during processing operations.
Code information: 1) Part No.: 14060546848; Batch No.s: 8280-10309, 82801-0310; 2) Part No.: 14060546846; Batch No.s: 1034710114; 3) Part No.: 14060546845; Batch No.s: 1021420914; 4) Part No.: 14060546933; Batch No.s: 82801-0217; 5) Part No.: 14060546932; Batch No.s: 1030730112, 1101110204; 6) Part No.: 14060546852; Batch No.s: 1101910322; 7) Part No.: 14060546850; Batch No.s: 1034710204, 1034710328, 1113910803; 8) Part No.: 14060546847; Batch No.s: 913920827
Distribution pattern: Worldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand.
Derived failure modes
-
Unknown
An LPC Fine Mesh Cassette failed to stay closed during processing operations.