Recall Z-0708-05 ยท MDB System, Blood Culturing
Trek Diagnostic Systems
Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case.
| Date | Apr 13, 2005 (initiated Mar 4, 2005) |
| Status | Terminated |
| Reason | Blood culture bottles with an error in the bar code on the labels, were shipped. |
| Root cause | Other |
| Action | The firm contacted its customers and notified them of the recall via telephone and fax on 3/4/2005 and a recall letter dated 3/4/2005 was sent to each customer via U.S. Mail on 3/7/2005. The letter states that a ''Return Goods Authorization'' for the amount of product shipped to each facility has been issued and asks that the customers return any unused portion of this lot to the firm for replacement. |
| Quantity | 223 cases [11,150 bottles] |
| Distribution | The blood culture bottles were distributed to the following states within the U.S.: MA, NY, TX, OH, MD, KY, OR, MO, NJ, PA, MI, FL, IN, NC, KS, GA, WI, & IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.