Z-1153-04

Synchron Systems Lipid Calibrator (HDLD) Part 650218

Name: Z-1153-04 Synchron Systems Lipid Calibrator (HDLD) Part 650218
Creator: Beckman Coulter Inc
Published: 2003-10-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-10-03 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc began a recall of Synchron Systems Lipid Calibrator (HDLD) Part 650218 on 2003-10-03. The reason FDA records is "Incorrect units are printed in labeling but not in software". 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-1153-04
Status: Terminated
Initiated: 2003-10-03
Posted: 2004-07-23
Terminated: 2004-08-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron Systems Lipid Calibrator (HDLD) Part 650218
Product code: JIS Calibrator, Primary
Reason for recall: Incorrect units are printed in labeling but not in software.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Letter was mailed which explains tha the units on the Value Sheet are printed incorrectly. Recall is complete.
Quantity in commerce: 2069
Distribution: Nationwide
Product codes and lots: Kit; M302210 Level 1; M302211 Level 2; M302212

Product code JIS

K983640Class IISynchron Systems Lipid CalibratorBeckman Coulter, Inc. / cleared 1998-12-21

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)