Z-1101-04

Synchron Systems Hemoglobin A1c (HbA1c) Reagent

Name: Z-1101-04 Synchron Systems Hemoglobin A1c (HbA1c) Reagent
Creator: Beckman Coulter Inc
Published: 2004-07-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-07-30 / Terminated / root cause: supplier

FDA source

Beckman Coulter Inc began a recall of Synchron Systems Hemoglobin A1c (HbA1c) Reagent on 2004-07-30. The reason FDA records is "Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1101-04
Status: Terminated
Initiated: 2004-07-30
Posted: 2004-07-20
Terminated: 2004-08-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron Systems Hemoglobin A1c (HbA1c) Reagent
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm.
Root cause tag: supplier
FDA root cause: Other
Product codes and lots: Part 650252 Product Lot Numbers: M206003 M209057

Product code JJY

K974452Class IVigil Lipid ControlBeckman Instruments, Inc. / cleared 1997-12-17

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)