Z-2231-2011

COULTER Ac"T" 5diff Fix Reagent. Part Number: 8547171 COULTER AC"T" 5diff Fix, Instructions for Use, PN...

Name: Z-2231-2011 COULTER Ac"T" 5diff Fix Reagent. Part Number: 8547171 COULTER AC"T" 5diff Fix, Instructions for Use, PN...
Creator: Beckman Coulter Inc.
Published: 2011-04-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-04-08 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of COULTER Ac"T" 5diff Fix Reagent. Part Number: 8547171 COULTER AC"T" 5diff Fix, Instructions for Use, PN 772264. Intended for use as a leukocyte reagent to... on 2011-04-08. The reason FDA records is "The recall was initiated because Beckman Coulter has confirmed that an issue has been identified with one of the raw materials used to manufacture the Coulter A T 5 diff PN 8547171". 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-2231-2011
Status: Terminated
Initiated: 2011-04-08
Posted: 2011-05-20
Terminated: 2012-06-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: COULTER Ac"T" 5diff Fix Reagent. Part Number: 8547171 COULTER AC"T" 5diff Fix, Instructions for Use, PN 772264. Intended for use as a leukocyte reagent to differentiate subpopulations of cells on COULTER Ac"T 5diff hematology analyzers. Intended for use only with specific Ac"T 5diff reagents. Refer to the instrument product manuals and/or online help, as applicable.
Product code: GGK Products, Red-Cell Lysing Products
Reason for recall: The recall was initiated because Beckman Coulter has confirmed that an issue has been identified with one of the raw materials used to manufacture the Coulter A T 5 diff PN 8547171.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Beckman Coulter initiated a Product Corrective Action (PCA) letter on April 8, 2011, with attached PCA Response Form to all customers who purchased the COULTER Ac"T" 5diff Fix Reagent. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discard the product according to their laboratory safety procedures and use the attached response form to request replacement product. All flagged results should be reviewed as outlined in the Instructions for Use manual and your laboratory protocol. A retrospective review of results is not required if all recommendations for review have been followed as shown in the Instructions for Use. Customers were instructed to share the information with their laboratory staff and to retain the notification as part of their Quality System documentation. If the product was further distirbuted to another laboratory, customers should provide them a copy of the notification letter. The raw material issue has been corrected beginning with COULTER A T 5diff Fix lot 16902E. Customers were instructed to complete and return the enclosed Response Form within ten (10) days. Customers with any questions concerning this notice, were instructed to contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.
Quantity in commerce: 4662 units total (2278 in US)
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Australia, Botswana, Bulgaria, Czech Republic, Estonia, Finland, France, Germany, Greece, Guyana, Italy, Japan, Kenya, Mexico, Morocco, Namibia, Netherlands, Nigeria, Philippines, Puerto Rico, Russian Federation, Slovakia, South Africa, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Zambia
Product codes and lots: Lot # 16602E, 16702E, 16802E

Product code GGK

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)