Z-2481-2015Class II

COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the...

Name: Z-2481-2015 COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the...
Creator: Beckman Coulter Inc.
Published: 2015-07-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-07-22 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types... on 2015-07-22. FDA classified it as Class II and gives the reason as "Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette". 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-2481-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-22
Posted: 2015-08-28
Terminated: 2015-12-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
Product code: GIF Diluent, Blood Cell
Reason for recall: Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent Medical Device Recall letter dated 7/22/15 was sent to the affected customers to inform them of the issue and actions to take. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions are instructed to contact Beckman Coulter's Customer Support Center, http://www.beckmancoulter.com/customersupport/support, (800) 526-7694 in US and Canada. Customers outside of the US and Canada, are instructed to contact their local Beckman Coulter Representative.
Quantity in commerce: 710 units
Distribution: Distributed US (nationwide) including Puerto Rico and U.S. Virgin Islands and the countries of Bermuda, Canada, Guatemala, Hong Kong, Mexico, Panama, Taiwan, and Trinidad-Tobago.
Product codes and lots: Lot Numbers: 18203F-18206F.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2481-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2480-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-28
Z-2481-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-28

Product code GIF

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)