Class 2 Device Recall McFarland Standard

• Date Initiated by Firm: September 22, 2008
• Date Posted: January 28, 2009
• Recall Status: Terminated on July 06, 2010
• Recall Number: Z-0669-2009
• Recall Event ID: 50129
• Product Classification: in vitro diagnostic - Product Code JTZ
• Product: HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box
• Code Information: Model Number: Hardy = MSO5; Lot number 08182; Expiration date: 10/28/08
• FEI Number: 1000515493
• Recalling Firm/ Manufacturer: Trek Diagnostic Systems; 982 Keynote Cir Ste 6; Cleveland OH 44131-1873
• For Additional Information Contact: Teresa Anacker; 608-837-3788 Ext. 224
• Manufacturer Reason for Recall: Incorrect result: The absorbance has changed as the standards have aged; the standards' turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK'S internal specification and the manufacturer's (Hardy Diagnostics) specification is 0.08 - 0.10 ABS @625 nm. CLSI specifies 0.08 - 0.13 ABS @ 625 nm.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 9/22/2008 TREK Diagnostic sent a recall notification letter to their customers advising them of the problem with the product. They instructed their customers to inventory their stock for any remaining recall lot and immediately destroy.
• Quantity in Commerce: 4 vials
• Distribution: USA distribution in OH and IL.
• 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.