—#33155

Product

Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.

FDA product code: MSS — Folders And Injectors, Intraocular Lens (Iol)
Device class: Class 1
Medical specialty: Ophthalmic
510(k) numbers: K010748, K973696
Affected lot / code info: CX: Level 1 -M206191, Level 2-M206192, Level 3-M206193, Level 4-M206194. LX: Level 1-M301121, Level 2- M301122, Level 3- M301122, Level 4-M301124.

Why it was recalled

Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.

Root cause (FDA determination)

Other

Recalling firm

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

Distribution

Timeline

Recall initiated: 2003-08-18
Posted by FDA: 2004-07-23
Terminated: 2004-08-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #33155. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.