Recall Z-1135-2021 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Medline Industries Inc
S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body -Hydroxybutyrate in serum or plasma. For laboratory use only.
| Date | Jan 15, 2021 |
| Status | Terminated |
| Reason | Medline Industries, Inc. is removing specific lots of STAT-Site Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment. |
| Root cause | Process control |
| Action | Medline sent an "URGENT RECALL NOTIFICATION" on 01/15/2021 to customers, requesting: 1. Immediately check your stock for the affected item number and the affected lot numbers listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization |
| Quantity | 46 units |
| Distribution | US Nationwide distribution in the states of MS, OH, IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.