Z-1446-2013Class II

LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845...

Name: Z-1446-2013 LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845...
Creator: Leica Microsystems, Inc.
Published: 2013-04-04
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2013-04-04 / Terminated / root cause: design

FDA source

Leica Microsystems, Inc. began a recall of LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850... on 2013-04-04. FDA classified it as Class II and gives the reason as "An LPC Fine Mesh Cassette failed to stay closed during processing operations". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1446-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-04
Posted: 2013-06-03
Terminated: 2017-07-21
Recalling firm: Leica Microsystems, Inc.
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.
Product code: IDZ Cassettes, Tissue
Reason for recall: An LPC Fine Mesh Cassette failed to stay closed during processing operations.
Root cause tag: design
FDA 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 in commerce: 20,160 units
Distribution: Worldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1446-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1446-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-03

Product code IDZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)