Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444

FDA Recall Z-1233-2020 · Posted 2020-01-24

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJFY
Date Initiated2019-12-18
Date Terminated2020-06-25
Product Quantity11,725 units

Reason for Recall

There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.

Firm Action

Siemens Healthcare Diagnostics initiated a customer communication for this issue via letter beginning December 18, 2019.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090330DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270Siemens Healthcare Diagnostics, Inc. · 2009-05-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑