Recall Z-0404-2022 ยท DIF Drug Mixture Control Materials
MEDLINE INDUSTRIES, LP - Northfield
Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
| Date | Nov 30, 2021 |
| Status | Terminated |
| Reason | Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment. |
| 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 |
| Quantity | 14 units (individual) |
| Distribution | US Nationwide distribution in the states of IL, OH, MS, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.