Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0770-2021 — VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry S

U.S. FDA — Device Enforcement · United States · 2020-12-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0770-2021
Date of alert
2020-12-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho Clinical Diagnostics Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10758750004294
Reported risk: VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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