Quantimetrix Urine Dipstick Control

• • Ongoing Z-0138-2025 FDA Class II ·initiated 17 Sep 2024

  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.

• • Terminated Z-2257-2018 FDA Class III ·initiated 21 Dec 2017

  The kits contained an incorrect lot of Dropper Plus Level 1 vials

• • Terminated Z-0514-2009 FDA Unclassified (pre-2012) ·initiated 1 Jun 2007

  This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.

510(k) Number

K874890 ↗

FDA Product Code

JJW

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Quantimetrix Urine Drugs of Abuse Control

  Class I

  FDA 510(k) K873467 Active Cleared 29 Sep 1987

• Quantimetrix Serum Alcohol Control Level 1 and 2

  Class I

  FDA 510(k) K873011 Active Cleared 29 Oct 1987

• Alkphor(Tm) System, Human Serum Alka Phos Isoenzy

  Class I

  FDA 510(k) K883395 Active Cleared 19 Sep 1988

• Quantimetrix Total Creatine Kinase Control

  Class I

  FDA 510(k) K874302 Active Cleared 2 Feb 1988

• Quantimetrix Serum Lipid Control I & II Liquid

  Class I

  FDA 510(k) K861448 Active Cleared 28 Apr 1986

• Quantimetrix Bilirubin Calibrators

  Class II

  FDA 510(k) K895778 Active Cleared 14 Nov 1989

See all devices from Quantimetrix Medical Industries →