Z-1026-04

Synchron Systems Acetaminophen Reagent, part No. 472169

Name: Z-1026-04 Synchron Systems Acetaminophen Reagent, part No. 472169
Creator: Beckman Coulter Inc
Published: 2003-09-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-09-04 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc began a recall of Synchron Systems Acetaminophen Reagent, part No. 472169 on 2003-09-04. The reason FDA records is "Firm shortened calibration frequency to 7 days from 14 days". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1026-04
Status: Terminated
Initiated: 2003-09-04
Posted: 2004-07-20
Terminated: 2005-01-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron Systems Acetaminophen Reagent, part No. 472169.
Product code: LDP Colorimetry, Acetaminophen
Reason for recall: Firm shortened calibration frequency to 7 days from 14 days.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Firm issued letters to customers indicating need to shorten the calibration period from 14 to 7 days.
Quantity in commerce: unknown
Distribution: Nationwide and Canada
Product codes and lots: All lots

Product code LDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)