MEDLINE INDUSTRIES, LP Northfield 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch Numbers
Lot numbers 172093, exp. 06/30/2023, 174703, exp. 08/31/2023, and 169141, exp. 04/30/2023.
Products Sold
Lot numbers 172093, exp. 06/30/2023; 174703, exp. 08/31/2023; and 169141, exp. 04/30/2023.
MEDLINE INDUSTRIES, LP Northfield is recalling Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 due to The product was stored incorrectly due to improper storage controls which may lead to delayed results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product was stored incorrectly due to improper storage controls which may lead to delayed results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, FL, NE, OH, TX, WA, WI
Page updated: Jan 10, 2026