Z-1155-04

Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent Part No.: 469905 Lot M206161 (level...

Name: Z-1155-04 Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent Part No.: 469905 Lot M206161 (level...
Creator: Beckman Coulter Inc
Published: 2003-08-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-08-15 / Terminated

FDA source

Beckman Coulter Inc began a recall of 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... on 2003-08-15. The reason FDA records is "LDL Cholesterol component in controls are unstable". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1155-04
Status: Terminated
Initiated: 2003-08-15
Posted: 2004-07-23
Terminated: 2004-08-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
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)
Product code: MRR System, Test, Low Density, Lipoprotein
Reason for recall: LDL Cholesterol component in controls are unstable.
FDA root cause: Other
Quantity in commerce: 1780 all lots.
Product codes and lots: CX: Level 1-M206161, Level 2-M206192, Level 4-M206194. LX Level 1-M301021, Level 2-M301122, Level 4-M301124.

Product code MRR

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)