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Recall Observatory FDA recall evidence

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

April 04, 2013

Class II

Product summary

Firm
Leica Microsystems, Inc.
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

    reason.no_named_rule · v1.0.0

    An LPC Fine Mesh Cassette failed to stay closed during processing operations.