Z-1616-2015Class II

COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in...

Name: Z-1616-2015 COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in...
Creator: Beckman Coulter Inc.
Published: 2015-04-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-04-13 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting... on 2015-04-13. FDA classified it as Class II and gives the reason as "Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The use of the DxH Diluent lots listed in the recall notice may...". 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-1616-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-13
Posted: 2015-05-15
Terminated: 2015-10-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.
Product code: GIF Diluent, Blood Cell
Reason for recall: Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The use of the DxH Diluent lots listed in the recall notice may eventually result in a compromised HGB chamber.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent Medical Device Recall letter dated 4/13/15 was sent to customers who purchased the Coulter DxH Diluent. The letter informs customers that Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The letter informs customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Center via http://www.beckmancoulter.com/customersupport/support or call (800) 526-7694 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
Quantity in commerce: 829,888 units total (659,584 units in US)
Distribution: Worldwide Distribution -- Argentina; Brazil; Brunei Darussalam; Canada; Chile; Colombia; Hong Kong; India; Lebanon; Macao; Mexico; Panama; Philippines; Qatar; Singapore; Taiwan; Thailand; Trinidad and Tobago; United States, including Puerto Rico; and Uruguay.
Product codes and lots: Lot No. 3099980 - 3512190, expiration dates: 17 April 2015 - 26 August 2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1616-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1616-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-20	2015-05-14

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)