Z-1099-04

LDL Cholesterol Reagent (LDLD) Part No. 969706

Name: Z-1099-04 LDL Cholesterol Reagent (LDLD) Part No. 969706
Creator: Beckman Coulter Inc
Published: 2003-02-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-02-10 / Terminated

FDA source

Beckman Coulter Inc began a recall of LDL Cholesterol Reagent (LDLD) Part No. 969706 on 2003-02-10. The reason FDA records is "Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1099-04
Status: Terminated
Initiated: 2003-02-10
Posted: 2004-07-20
Terminated: 2004-12-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: LDL Cholesterol Reagent (LDLD) Part No. 969706
Product code: MRR System, Test, Low Density, Lipoprotein
Reason for recall: Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date.
FDA root cause: Other
Quantity in commerce: 291
Product codes and lots: Lot M210044

Product code MRR

K014103Class ISynchron Systems Direct Ldl Chloesterol Reagent and CalibratorBeckman Coulter, Inc. / cleared 2002-01-28

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)