FDAClass IIDecember 29, 2021

Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls recall

Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605

Why was Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls recalled?

Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No.: S-O2460605; Batch No.: 161603, 165148, 156205, 158144, 169124, 171961, and 175250; Serial No.:161603, 165148, 156205, 158144, 169124, 171961, and 175250.

Product
Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
14 units (individual)
Distribution
US Nationwide distribution in the states of IL, OH, MS, and PA.
Recall date
December 29, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls