Z-0404-2022Class II

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

Name: Z-0404-2022 Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2021-11-30
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2021-11-30 / Terminated

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605 on 2021-11-30. FDA classified it as Class II and gives the reason as "Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0404-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-30
Posted: 2021-12-21
Terminated: 2023-01-06
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Product code: DIF Drug Mixture Control Materials
Reason for recall: Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
FDA root cause: Storage
Action: The firm distributed an Urgent Recall Notification, dated 11/30/2021, to customers who purchased recalled product via first class mail. The notification informs customers that the firm is initiating a removal of Trilevel Serum Matrix Free from S-O2460605 kits due to product being compromised during shipment. Customers are instructed to immediately check their stock for affected product, quarantine any lot numbers associated with the recall, and destroy affected product. Customers were provided an Urgent Remedial Action Destruction Form to complete and return to the firm to indicate whether or not they possess recalled product and document product destruction. Completed forms are to be returned to the firm via email at [email protected] or by fax at 866-767-1290. If product was further distributed, customers are required to share the recall notification down the distribution chain. Customers with any questions about the recall are instructed to call 866-359-1704.
Quantity in commerce: 14 units (individual)
Distribution: US Nationwide distribution in the states of IL, OH, MS, and PA.
Product codes and lots: Model No.: S-O2460605; Batch No.: 161603, 165148, 156205, 158144, 169124, 171961, and 175250; Serial No.:161603, 165148, 156205, 158144, 169124, 171961, and 175250.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0404-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0404-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-29	2021-12-21

Product code DIF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)