Recall Z-1407-2021 ยท JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Medline Industries Inc
Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.
| Date | Mar 15, 2021 |
| Status | Open, Classified |
| Reason | Possible false negative or false positive results due to the product being compromised during shipment. |
| Root cause | Storage |
| Action | The firm sent an Urgent Recall Notification to its customers on 3/15/21 with the following instructions: 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. When we receive your completed destruction form your account will receive credit, if applicable. 3. If you have trans |
| Quantity | 24 each |
| Distribution | US Nationwide distribution in the state of Ohio. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.