FDA Medical Device Recalls (openFDA)
Leica Biosystems Richmond Inc.: Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of preservative containing polyethylene glycol for the convenient collection, fixation and preservation of all cytologic specimens, 50 jars per case; for in vitro diagnostic use only; Leica Biosystems, 5205 Rt. 12, Richmond, IL 60071; Made in USA The Cyto Jar is for the convenient collection, fixation and preservation of all cytologic specimens. The 120 mL clear, leakproof container is prefilled with 45 mL of preservative containing polyethylene glycol. It can be used for rinsing aspiration needles or bronchial brushes and for the direct collection of sputum specimens.
- Recall number
- Z-1331-2012
- Recalling firm
- Leica Biosystems Richmond Inc.
- Product
- Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of preservative containing polyethylene glycol for the convenient collection, fixation and preservation of all cytologic specimens, 50 jars per case; for in vitro diagnostic use only; Leica Biosystems, 5205 Rt. 12, Richmond, IL 60071; Made in USA The Cyto Jar is for the convenient collection, fixation and preservation of all cytologic specimens. The 120 mL clear, leakproof container is prefilled with 45 mL of preservative containing polyethylene glycol. It can be used for rinsing aspiration needles or bronchial brushes and for the direct collection of sputum specimens.
- Status
- Terminated
- Initiated
- 2012-02-20
- Posted
- 2012-03-29
- Terminated
- 2012-09-20
- Reason
- Product was distributed with the incorrect lot number and expiration date. The lot number and expiration date should have been listed at 073013 and instead was noted as 073014 which is beyond the maximum expiration dating of 18 months for this product.
- Root cause
- Process design
- Action
- The firm, Leica Microsystems, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 17, 2012, via FedEx on February 20, 2012 to all affected customers. The letter describes the product, problem, and actions to be taken. A second letter was sent to the customers on February 29, 2012, clarifying that the incorrect lot number and expiration date was 073014, and should have been 073013. The customers were instructed to discontinue use of the product; return the product and complete and return the enclosed Acknowledgement Form via fax to 815-678-2216 within one week of receiving the notification. If you have any questions, contact the Regulatory Affairs Manager at toll free (800) 225-8867 or email: richmond@leica-microsystems.com.
- Quantity
- 11 cases
- Distribution
- Nationwide distribution: USA including states of: Michigan, Missouri and New York.
- Lot, serial or model codes
- item #3801825, reorder #01825, lot #073013
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LEA
- Firm FEI
- 1419341
- Firm city
- Richmond
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28