The U.S. Food and Drug Administration (FDA) posted a medical device safety alert concerning 10% Neutral Buffered Formalin (NBF), manufactured by Thermo Scientific Richard-Allan Scientific. The product details are as follows:

• Cardinal Health Prefilled Buffered 10% Formalin (Product code: C4320-450B; Lot no.: 300403);
• Richard-Allan Scientific Specimen Transportation System (Product code: 53151 and 534801; Lot no.: 300143 and 296986);
• Richard-Allan Scientific 10% NBF (Product code: 51401 and LC-0060; Lot no.: 300649 and 300445);
• Richard-Allan Scientific Bio-Tite Specimen Containers (Product code: 59601; Lot no.: 300233);
• Protocol 10% NBF Product (Product code: 426-796; Lot no.: 298987)

The affected lots could have NBF concentrations that are lower or higher than the desired specifications.

For details, please refer to the FDA website
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=69276&w=10152014??eng

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 17 October 2014