Recall Z-0669-2009 ยท JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Trek Diagnostic Systems
HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box
| Date | Jan 28, 2009 (initiated Sep 22, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 4 vials |
| Distribution | USA distribution in OH and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.