Recall Z-3054-2020 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Medline Industries Inc
Control, Calibrator Verified, Triage BNP, Model ALR88755
| Date | Jul 28, 2020 |
| Status | Terminated |
| Reason | Product was shipped with refrigeration (ice) instead of frozen (dry ice). |
| Root cause | Process control |
| Action | Medline Industries sent formal letters with response forms to affected consignees via 1st class mail on August 3, 2020. Customers were asked to initiate sub-recalls where appropriate. Consignees were provided with a destruction form to return via fax or email. Each destruction form received with be recorded and Medline Industries, Inc. will send subsequent letters to consignees that have not provided a response to the recall notification in the allotted time. Consignees are asked to confirm the destruction of any affected product on hand. |
| Quantity | 118 units |
| Distribution | Distribution in US - AR, AZ, CO, FL, MD, MS, MI, NC, NM, NY, OK, PA, RI, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072892 | TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 Biosite Incorporated, Dec 7, 2007 |