ClearanceBrief
Recall Z-1156-04 ยท MSS Folders And Injectors, Intraocular Lens (Iol)

Beckman Coulter Inc

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

DateJul 23, 2004 (initiated Aug 18, 2003)
StatusTerminated
ReasonValues for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.
Root causeOther
Quantity5275
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K010748SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
Beckman Coulter, Inc., Jul 10, 2001
K973696SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
Beckman Instruments, Inc., Nov 24, 1997