Recall Z-2257-2018 ยท JJW Urinalysis Controls (Assayed And Unassayed)
Quantimetrix Corporation
Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest reagent tablets, and for hCG methods.
| Date | Dec 21, 2017 |
| Status | Terminated |
| Reason | The kits contained an incorrect lot of Dropper Plus Level 1 vials |
| Root cause | Mixed-up of materials/components |
| Action | Communication with their only customer for this recall was via e-mail and phone. Upon notification by the customer the following activities were initiated: All lots of the Dropper Plus product in inventory were 100% inspected. The customer was ask to return all of the kits to Quantimetrix. For further questions please call (310) 536-0006. |
| Quantity | 20 kits |
| Distribution | US Distribution to the state of : Kansas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K874890 | QUANTIMETRIX URINE DIPSTICK CONTROL Quantimetrix Medical Industries, Jan 21, 1988 |