Remel Inc: Medical Device Recall in 2014 - (Recall #: Z-2057-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 11, 2014

Date Posted: July 23, 2014

Recall Number: Z-2057-2014

Event ID: 68583

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.

Status: Terminated

Product Quantity: 76/50-bottle boxes

Code Information:

Segments 1, 5, and 6 only of Lot 492571, Exp. 2015-10

Distribution Pattern:

Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.

Voluntary or Mandated:

Voluntary: Firm initiated