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U.S. Department of Health and Human Services

Class 3 Device Recall Cyto Jar Fixative

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  Class 3 Device Recall Cyto Jar Fixative see related information
Date Initiated by Firm February 20, 2012
Date Posted March 29, 2012
Recall Status1 Terminated 3 on September 20, 2012
Recall Number Z-1331-2012
Recall Event ID 61276
Product Classification Preservative, cytological - Product Code LEA
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.
Code Information item #3801825, reorder #01825, lot #073013
Recalling Firm/
Manufacturer		 Leica Biosystems Richmond Inc.
5205 Route 12
Richmond IL 60071
For Additional Information Contact
815-678-2000
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 11 cases
Distribution Nationwide distribution: USA including states of: Michigan, Missouri and New York.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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