Recalls / —
—#33141
Product
Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent Part No.: 469905 Lot M206161 (level 1) Part No.: 465980 Lot M206192 (level 2) Part No.: 465982 Lot M206194 (level 4) Part No.: 465421 Lot M301121 (level 1) part No.: 465422 Lot M301122 (level 2) Part No.: 465424 Lot M301124 (level 4)
- FDA product code
- MRR — System, Test, Low Density, Lipoprotein
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K010748, K973696
- Affected lot / code info
- CX: Level 1-M206161, Level 2-M206192, Level 4-M206194. LX Level 1-M301021, Level 2-M301122, Level 4-M301124.
Why it was recalled
LDL Cholesterol component in controls are unstable.
Root cause (FDA determination)
Other
Recalling firm
- Firm
- Beckman Coulter Inc
- Address
- 200 S Kraemer Blvd, Brea, California 92822-6208
Distribution
Timeline
- Recall initiated
- 2003-08-15
- Posted by FDA
- 2004-07-23
- Terminated
- 2004-08-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #33141. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.