Chromascopics Control Level 1&2 Set 4x120mL (International)
QUANTIMETRIX CORPORATION · Model 1540-01 · UDI-DI 00896863002035
Description
The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus Automated Urine Chemistry Analyzer and Atellica 800 and 1500 systems. It is also compatible with Siemens urinalysis dipsticks, confirmatory tests, and qualitative methods. It may also be used as a means of validating the processing and centrifugation of patient urine samples prior to the microscopic evaluation of urine sediment. It is supplied as a liquid, ready-to-use control in two levels, configured with 2x120mL of each level per box. It does not required reconstitution or dilution. They are prepared from human urine to which stabilized human red and white blood cells, calcium oxalate crystals, non-pathogenic bacteria, and other compounds have been added to produce desired reactions 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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