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Terminated

HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box

FDA Recall Z-0669-2009 · Posted 2009-01-28

Recalling FirmTrek Diagnostic Systems
Recall StatusTerminated
Product CodeJTZ
Date Initiated2008-09-22
Date Terminated2010-07-06
Product Quantity4 vials

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

USA distribution in OH and IL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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