—#192475

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.

FDA product code: DKB — Calibrators, Drug Mixture
Device class: Class 2
Medical specialty: Clinical Toxicology
Affected lot / code info: Lot numbers 172093, exp. 06/30/2023; 174703, exp. 08/31/2023; and 169141, exp. 04/30/2023.

Why it was recalled

The product was stored incorrectly due to improper storage controls which may lead to delayed results.

Root cause (FDA determination)

Storage

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution.

Timeline

Recall initiated: 2022-03-08
Terminated: 2023-02-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192475. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.