—#33132

Product

LDL Cholesterol Reagent (LDLD) Part No. 969706

FDA product code: MRR — System, Test, Low Density, Lipoprotein
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K014103
Affected lot / code info: Lot M210044

Why it was recalled

Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date.

Root cause (FDA determination)

Other

Recalling firm

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

Distribution

Timeline

Recall initiated: 2003-02-10
Posted by FDA: 2004-07-20
Terminated: 2004-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #33132. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.