Home › Device types › JJW
Urinalysis Controls (Assayed And Unassayed)
FDA product code JJW · Class 1 · Clinical Chemistry
217
Registered devices
31
Adverse events
22
Recalls
61
510(k) clearances
Devices with this code
MAS® UrichemTRAK Liquid Assayed Urine Control — Microgenics CorporationqUAntify — BIO-RAD LABORATORIES, INC.IRISpec — IRIS INTERNATIONAL, INC.KOVA — KOVA INTERNATIONAL, INC.MAS Urinalysis Liquid Urinalysis Control 3 — Microgenics CorporationIRISpec — BECKMAN COULTER IRELAND INC.KOVA — KOVA INTERNATIONAL, INC.qUAntify — BIO-RAD LABORATORIES, INC.Liquichek — BIO-RAD LABORATORIES, INC.qUAntify — BIO-RAD LABORATORIES, INC.Cardinal Health — KOVA INTERNATIONAL, INC.KOVA — KOVA INTERNATIONAL, INC.KOVA — KOVA INTERNATIONAL, INC.KOVA — KOVA INTERNATIONAL, INC.NA — ALTA DIAGNOSTICS INCDipper Urinalysis Dipstick Control Level 2 Set 6x15mL — QUANTIMETRIX CORPORATIONChek-Stix® Combo Pak Control+ Control- Strips — Siemens Healthcare Diagnostics Inc.KOVA — KOVA INTERNATIONAL, INC.MICROALBUMIN Urine Level 1 and 2 — SEKISUI DIAGNOSTICS, LLCKOVA — KOVA INTERNATIONAL, INC.KOVA — KOVA INTERNATIONAL, INC.Dropper Urine Chemistry Control Level 1 Set 3x25mL — QUANTIMETRIX CORPORATIONDropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 10x5mL — QUANTIMETRIX CORPORATIONChromascopics Control Level 1&2 Set 4x120mL (International) — QUANTIMETRIX CORPORATION
Recent 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; |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 concentratio |
| 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: UA151401 |
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