CLASS II Device recall · Reported 29 Dec 2021 · FDA Enforcement Report

Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls recalled

Medline Industries LP - Northfield is recalling Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, distributed nationwide in the US. The recall was initiated on 30 Nov 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No.: S-O2460605; Batch No.: 161603, 165148, 156205, 158144, 169124, 171961, and 175250; Serial No.:161603, 165148, 156205, 158144, 169124, 171961, and 175250.

Quantity recalled14 units (individual)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0404-2022
FDA event ID: 89150
Recalling firm: Medline Industries LP - Northfield, Northfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 30 Nov 2021
FDA classified: 21 Dec 2021
Reported: 29 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

30 Nov 2021	Recall initiated by company
21 Dec 2021	Classified by FDA	+21 days
29 Dec 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of IL, OH, MS, and PA.

Nationwide Illinois Mississippi Ohio Pennsylvania

Questions about this recall

Why was it recalled?

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

Which lots 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.

Where was it sold?

US Nationwide distribution in the states of IL, OH, MS, and PA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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