| Date Initiated by Firm |
September 22, 2008 |
| Date Posted |
January 28, 2009 |
| Recall Status1 |
Terminated 3 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 |
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 2 |
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.
|
