Z-1331-2012

Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of preservative...

Name: Z-1331-2012 Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of preservative...
Creator: Leica Biosystems Richmond Inc.
Published: 2012-02-20
License: https://open.fda.gov/license/

Leica Biosystems Richmond, Inc. / initiated 2012-02-20 / Terminated / root cause: manufacturing process

FDA source

Leica Biosystems Richmond Inc. began a recall of Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of preservative containing polyethylene glycol for the convenient... on 2012-02-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1331-2012
Status: Terminated
Initiated: 2012-02-20
Posted: 2012-03-29
Terminated: 2012-09-20
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.
Product code: LEA Preservative, Cytological
Reason for recall: 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 tag: manufacturing process
FDA 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: [email protected].
Quantity in commerce: 11 cases
Distribution: Nationwide distribution: USA including states of: Michigan, Missouri and New York.
Product codes and lots: item #3801825, reorder #01825, lot #073013

Product code LEA

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)