Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL Pretreatment Solution (sodium thiocyana

FDA device recall Z-1147-2010 · posted 2010-03-16 · Terminated

Recall details

Recalling firm

Abbott Molecular

Reason for recall

The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.

Action taken

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.

Root cause

Package design/selection

Status

Terminated

Product code

KEO

Quantity affected

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, Pana

Date initiated

2010-01-22

Date posted

2010-03-16

Date terminated

2012-01-29

Location

Des Plaines, IL