Z-0933-2022Class II

Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each...

Name: Z-0933-2022 Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-03-08
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-03-08 / Terminated

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604... on 2022-03-08. FDA classified it as Class II and gives the reason as "The product was stored incorrectly due to improper storage controls which may lead to delayed results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0933-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-08
Posted: 2022-04-14
Terminated: 2023-02-27
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.
Product code: DKB Calibrators, Drug Mixture
Reason for recall: The product was stored incorrectly due to improper storage controls which may lead to delayed results.
FDA root cause: Storage
Action: The recalling firm issued letters dated 3/8/2022 via regular mail on 3/8/2022. The letter explained the product was stored incorrectly due to improper storage controls. The consignee was to immediately check their inventory for the affected lot numbers, quarantine it, and destroy it. The enclosed destruction form was to be completed listing the quantity of affected product destroyed and once the form was returned, they would receive credit. If the product was transferred to another individual or location, they were to notify them of the recall communication. On 3/17/2022, the recalling firm issued an amended recall letter dated 3/17/2022 that notified the consignee there was an error in one of the lot numbers (1747003) listed in the original letter dated 3/8/2022 and the correct lot number is 174703. The other lot numbers were also listed in the amended letter. Again, return of the amended Destruction Form listing all of the lot numbers was requested containing the same instructions as the original Destruction Form.
Quantity in commerce: 10 boxes
Distribution: Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution.
Product codes and lots: Lot numbers 172093, exp. 06/30/2023; 174703, exp. 08/31/2023; and 169141, exp. 04/30/2023.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0933-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0933-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-14

Product code DKB

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)