Z-1156-04

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

Name: Z-1156-04 Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent
Creator: Beckman Coulter Inc
Published: 2003-08-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-08-18 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc began a recall of Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent on 2003-08-18. The reason FDA records is "Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1156-04
Status: Terminated
Initiated: 2003-08-18
Posted: 2004-07-23
Terminated: 2004-08-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.
Product code: MSS Folders And Injectors, Intraocular Lens (Iol)
Reason for recall: 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 tag: labeling and UDI
FDA root cause: Other
Quantity in commerce: 5275
Product codes and lots: 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.

Product code MSS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)