—#32874

Product

Synchron Systems Hemoglobin A1c (HbA1c) Reagent

FDA product code: JJY — Multi-Analyte Controls, All Kinds (Assayed)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K974452
Affected lot / code info: Part 650252 Product Lot Numbers: M206003 M209057

Why it was recalled

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

Root cause (FDA determination)

Other

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Timeline

Recall initiated: 2004-07-30
Posted by FDA: 2004-07-20
Terminated: 2004-08-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #32874. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.