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U.S. Department of Health and Human Services

Class 2 Device Recall Vysis Paraffin Pretreatment Reagent Kit II

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  Class 2 Device Recall Vysis Paraffin Pretreatment Reagent Kit II see related information
Date Initiated by Firm January 22, 2010
Date Posted March 16, 2010
Recall Status1 Terminated 3 on January 29, 2012
Recall Number Z-1147-2010
Recall Event ID 54190
Product Classification pathology fixative - Product Code KEO
Product Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL Pretreatment Solution (sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer II (0.2N HCl), 5 x 250 mg Protease I (Pepsin, lyophilized, activity 1:3000 to 1:3500); Abbott Molecular Inc; list 07J02-002, part number 32-801210. invitro diagnostic.
Code Information list 07J02-002, part number 32-801210, lot numbers 420563, 420008 and 418294
Recalling Firm/
Abbott Molecular
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information Contact Ms. Paula Martin
Manufacturer Reason
for Recall
The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.
FDA Determined
Cause 2
Package design/selection
Action Abbott Molecular sent Field Correction Letter/Urgent Field Safety Notice letters dated 1/21/10 to the Paraffin Pretreatment Regent Kit customers on 1/22/10, informing them that the MSDA symbology for hazardous and corrosive material is missing from the Paraffin Pretreatment Regent Kit II and Paraffin Pretreatment Regent Kit III labels. The information is missing from the vial label, kit label and package insert. The letter listed the risk and safety statements that should be included in the package insert, and advised the customers should use the kits in accordance with the listed risk and safety statements. The accounts were instructed to review this information with laboratory personnel and retain the letter for future reference, making copies of the letter and placing them in each kit in stock. Any questions were directed to their local Abbott Molecular Representative. Abbott Molecular plans to telephone each customer to ensure that they have received the letter and have disseminated the information to their laboratory personnel.
Quantity in Commerce 305 kits
Distribution Worldwide distribution: USA, Argentina, Austria, Belarus, Belgium, Canada, Colombia, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Kuwait, Lebanon, Lithuania, the Netherlands, Panama, Poland, Singapore, Slovenia, South Africa, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Vietnam.
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.