Z-2405-2008

Synchron Acetaminophen (ACTM) Reagent, Part Number 472169. ACTM Reagent when used in conjunction with...

Name: Z-2405-2008 Synchron Acetaminophen (ACTM) Reagent, Part Number 472169. ACTM Reagent when used in conjunction with...
Creator: Beckman Coulter Inc
Published: 2008-07-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-07-10 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc began a recall of Synchron Acetaminophen (ACTM) Reagent, Part Number 472169. ACTM Reagent when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 Systems and... on 2008-07-10. The reason FDA records is "This recall was initiated after Beckman Coulter verified through testing that Acetaminophen reagents (lots #M702524 & M703276) manufactured with contaminated heparin has shown a negative bias in performance between the...". 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-2405-2008
Status: Terminated
Initiated: 2008-07-10
Posted: 2008-09-25
Terminated: 2012-07-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron Acetaminophen (ACTM) Reagent, Part Number 472169. ACTM Reagent when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 Systems and SYNCHRON Systems Drug Calibrator 2 set, is intended for quantitative determination of Acetaminophen concentration in human serum or plasma.
Product code: LDP Colorimetry, Acetaminophen
Reason for recall: This recall was initiated after Beckman Coulter verified through testing that Acetaminophen reagents (lots #M702524 & M703276) manufactured with contaminated heparin has shown a negative bias in performance between the assay made with contaminated and uncontaminated heparin.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The initial customer notifications with fax back response forms were mailed via US Postal Service beginning on 07/21/2008. The letter asked their customers to please discontinue use and discard appropriately the affected lots of Synchron Acetaminophen Reagent (M703276 & M702524). Customers were also instructed to contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or, if they are outside the US or Canada, please contact your local Beckman Coulter Representative to discuss replacement options. They were also instructed to complete and return the enclosed response form within 10 days. In addition, the customers were informed that the contaminated Heparin was used in the following Beckman Coulter, Inc., products: Synchron Theophylline (THE) Reagent (lot # M701460), Synchron Phenytoin (PHY) Reagent and Synchron C-Reactive Protein (CRP) Reagent (lot# M703222, M703266, M703267 & M703268), however Beckman Coulter has verified through testing that the performance of these products are not affected.
Quantity in commerce: 7764 test kits
Distribution: Nationwide and Canada
Product codes and lots: Lot Numbers M703276 and M702524

Product code LDP

K000494Class IISynchron Systems Acetaminophen (Actm) ReagentBeckman Coulter, Inc. / cleared 2000-04-14

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)