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CueSee® VeriSTAT LVM

Eurotrol B.V. · Model 220.000.005 · UDI-DI 08718734961468

JJY Prescription
1
510(k) clearances
121
Adverse events
91
Recalls
128
Facilities

Description

CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. A box of CueSee® VeriSTAT LVM contains 5 levels of control material: CueSee® VeriSTAT LVM Level 1 - 08718734961413 CueSee® VeriSTAT LVM Level 2 - 08718734961420 CueSee® VeriSTAT LVM Level 3 - 08718734961437 CueSee® VeriSTAT LVM Level 4 - 08718734961444 CueSee® VeriSTAT LVM Level 5 - 08718734961451

Recalls

DateFirmReason
2025-10-06POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLCA labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The c
2025-10-01Microgenics CorporationThe firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in p
2025-04-24Mckesson Medical-Surgical Inc. Corporate Officetransit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur
2025-04-24Mckesson Medical-Surgical Inc. Corporate Officetransit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur
2025-04-24Mckesson Medical-Surgical Inc. Corporate Officetransit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur
2024-02-27Ortho-Clinical DiagnosticsThe issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) re
2024-02-27Ortho-Clinical DiagnosticsThe issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) re
2024-01-09Mckesson Medical-Surgical Inc. Corporate OfficeFacility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 De
2024-01-09Mckesson Medical-Surgical Inc. Corporate OfficeFacility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 De
2023-08-25TECHNO-PATH MANUFACTURING LTD.Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, M

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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.