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Dipper Urinalysis Dipstick Control Level 2 Set 6x15mL

QUANTIMETRIX CORPORATION · Model 1442-61 · UDI-DI 00896863002141

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Dipper 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. They are supplied in two levels as 6x15mL, three tubes of each level or 6x15mL level 2 only. They are liquid, ready-to-use requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth.

Recalls

Date	Firm	Reason
2025-11-22	Changchun Wancheng Bio-Electron Co., Ltd.	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause fa
2024-09-17	Mckesson Medical-Surgical Inc. Corporate Office	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 i
2024-07-16	Beckman Coulter, Inc.	Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results whe
2022-11-18	Beckman Coulter, Inc.	Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iC
2022-02-16	Beckman Coulter, Inc.	IRISpec CA failures for glucose.
2020-04-20	Cardinal Health Inc.	Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdi
2019-07-25	Randox Laboratories Ltd.	Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
2017-12-21	Quantimetrix Corporation	The kits contained an incorrect lot of Dropper Plus Level 1 vials
2014-02-06	Lin-Zhi International Inc	Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards t
2013-10-29	Thermofisher Scientive	Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stability specifications for Lot: UA1514011.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.