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KOVA
KOVA INTERNATIONAL, INC. · Model 87327E · UDI-DI 00855617006293
1
510(k) clearances
31
Adverse events
22
Recalls
36
Facilities
Description
KOVA-Trol III Normal w/hCG (4x60 mL)
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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Get your free API keyRead the docsData 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.