Recalls / —
—#190645
Product
Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
- FDA product code
- DIF — Drug Mixture Control Materials
- Device class
- Class 1
- Medical specialty
- Clinical Toxicology
- Affected lot / code info
- Model No.: S-O2460605; Batch No.: 161603, 165148, 156205, 158144, 169124, 171961, and 175250; Serial No.:161603, 165148, 156205, 158144, 169124, 171961, and 175250.
Why it was recalled
Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
Root cause (FDA determination)
Storage
Action the firm took
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 recalls@medline.com 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.
Recalling firm
- Firm
- MEDLINE INDUSTRIES, LP Northfield
- Address
- 3 Lakes Dr, Northfield, Illinois 60093-2753
Distribution
- Distribution pattern
- US Nationwide distribution in the states of IL, OH, MS, and PA.
Timeline
- Recall initiated
- 2021-11-30
- Terminated
- 2023-01-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #190645. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.