Z-0708-05

Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles

Name: Z-0708-05 Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles
Creator: Trek Diagnostic Systems
Published: 2005-03-04
License: https://open.fda.gov/license/

Trek Diagnostic Systems, Ltd. / initiated 2005-03-04 / Terminated / root cause: labeling and UDI

FDA source

Trek Diagnostic Systems began a recall of 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 on 2005-03-04. The reason FDA records is "Blood culture bottles with an error in the bar code on the labels, were shipped". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0708-05
Status: Terminated
Initiated: 2005-03-04
Posted: 2005-04-13
Terminated: 2005-12-28
Recalling firm: Trek Diagnostic Systems, Ltd.
Product: 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.
Product code: MDB System, Blood Culturing
Reason for recall: Blood culture bottles with an error in the bar code on the labels, were shipped.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Lot #144444SA, Expiration Date: 01/2006.

Product code MDB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)