Recall Z-0138-2025 ยท JJW Urinalysis Controls (Assayed And Unassayed)
Mckesson Medical-Surgical Inc. Corporate Office
Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.
| Date | Oct 22, 2024 (initiated Sep 17, 2024) |
| Status | Open, Classified |
| Reason | The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25C. This may lead to delay in patients' results. |
| Root cause | Packaging process control |
| Action | McKesson issued Urgent Product Recall letter via FedEx Overnight service scheduled for delivery on 9/17/24 to one consignee. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine all product subject to this urgent product recall detailed in the affected products list (Attachment #1). 2. Please complete, sign, and return the enclosed response form (Attachment #2 - Customer Response Form) as soon as possible, even if you do not have any product on hand. Return completed signed form MMSQARecalls@McKesson.com. 3. If you have any produ |
| Quantity | 1 BOX |
| Distribution | US Nationwide distribution in the state of DC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K874890 | QUANTIMETRIX URINE DIPSTICK CONTROL Quantimetrix Medical Industries, Jan 21, 1988 |