Data Foundry

Medical device recalls 2014

Thermo Scientific VersaTREK REDOX 1 — Class II medical device recall Z-2057-2014

Terminated recall by Remel Inc, reported 2014-07-23, distributed in CO, IL, IN, NE, NJ, PA, SD. Bottles did not provide positive signals within the time frame of the quality control specification for one of

Recall numberZ-2057-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmRemel Inc, Lenexa, KS, United States
Recall initiated2014-06-11
Classified2014-07-15
Reported by FDA2014-07-23
Terminated2014-08-28
DistributedCO, IL, IN, NE, NJ, PA, SD
Lot numbers2015-10, 492571
Model numbers7102-44

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2057-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.