Z-2057-2014Class II

Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The...

Name: Z-2057-2014 Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The...
Creator: Remel Inc
Published: 2014-06-11
License: https://open.fda.gov/license/

Remel Inc / initiated 2014-06-11 / Terminated / root cause: manufacturing process

FDA source

Remel Inc began a recall of Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS on 2014-06-11. FDA classified it as Class II and gives the reason as "Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2057-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-11
Posted: 2014-07-15
Terminated: 2014-08-28
Recalling firm: Remel Inc
Product: Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
Product code: MDB System, Blood Culturing
Reason for recall: Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recalling firm made phone calls to their customers beginning 6/11/14 with follow-up letters dated 6/12/14 being issued via regular mail requesting the affected product be destroyed. Additional customers were later identified and additional phone calls were made on 6/16/14 and recall letters dated 6/16/14 were issued via regular mail.
Quantity in commerce: 76/50-bottle boxes
Distribution: Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.
Product codes and lots: Segments 1, 5, and 6 only of Lot 492571, Exp. 2015-10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2057-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2057-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-15

Product code MDB

K032306Class IVersatrekTrek Diagnostic Systems, Inc. / cleared 2003-08-22

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)