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

Synchron Systems Hemoglobin A1c (HbA1c) Reagent

FDA Recall Z-1101-04 · Posted 2004-07-20

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJJY
Date Initiated2004-07-30
Date Terminated2004-08-30

Reason for Recall

Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm.

Root Cause

Other

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974452VIGIL LIPID CONTROLBeckman Instruments, Inc. · 1997-12-17

Official Source

View FDA Recall →

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

↑