Recall Z-1446-2013
Leica Microsystems, Inc. · initiated April 4, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
Reason for recall
An LPC Fine Mesh Cassette failed to stay closed during processing operations.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1446-2013
- Initiated
- April 4, 2013
- Posted by FDA
- June 3, 2013
- Terminated
- July 21, 2017
- Product code
- IDZ – Cassettes, Tissue
- Quantity
- 20,160 units
- Distribution
- Worldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand.
- Recalling firm
- Leica Microsystems, Inc., Buffalo Grove, IL