Recall Z-2257-2018— Quantimetrix Corporation
Class III · Terminated
Class III FDA medical device recall by Quantimetrix Corporation, initiated 2017-12-21, terminated 2021-01-27. It names one FDA 510(k) clearance: K874890. Product: 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.. Reason: The kits contained an incorrect lot of Dropper Plus Level 1 vials.
- Recalling firm
- Quantimetrix Corporation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2017-12-21
- Terminated
- 2021-01-27
- Firm location
- Redondo Beach, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The kits contained an incorrect lot of Dropper Plus Level 1 vials
Data sourced from openFDA. This site is unofficial and independent of the FDA.