Z-0902-06

Unicel DxC 600/800 SYNCHRON Clinical Systems; Operating Software Version 1.0 and 1.2; Part Number: A20463 and...

Name: Z-0902-06 Unicel DxC 600/800 SYNCHRON Clinical Systems; Operating Software Version 1.0 and 1.2; Part Number: A20463 and...
Creator: Beckman Coulter Inc
Published: 2006-03-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-03-15 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of Unicel DxC 600/800 SYNCHRON Clinical Systems; Operating Software Version 1.0 and 1.2; Part Number: A20463 and A27331 on 2006-03-15. The reason FDA records is "It was confirmed that the ORDAC (Over Range Detection And Correction) feature (auto & manual) does not perform correctly for the glucose cup chemistry (GLUCm) when sample type of 'Other' is selected w/operating software...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0902-06
Status: Terminated
Initiated: 2006-03-15
Posted: 2006-05-25
Terminated: 2012-04-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Unicel DxC 600/800 SYNCHRON Clinical Systems; Operating Software Version 1.0 and 1.2; Part Number: A20463 and A27331
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: It was confirmed that the ORDAC (Over Range Detection And Correction) feature (auto & manual) does not perform correctly for the glucose cup chemistry (GLUCm) when sample type of 'Other' is selected w/operating software versions 1.0 & 1.2. Results for these samples could be elevated as much as twice the actual value. The ORDAC feature does function properly w/serum, plasma, urine & CSF.
Root cause tag: software
FDA root cause: Other
Action: User Notification: A Product Corrective Action (PCA) letter will be sent the week of MAR 15, 2006 to all Synchron LX20, LX20PRO, LXi 725, and UniCel DxC 600/800 customers to inform them of the limitation for the use of fluid type 'Other' when programmed in combination with automatic or manual ORDAC for a GLUCm test. Customers are requested to implement one of three workarounds described in the PCA. IN PROCESS Stock Control: 1) A STOP SHIP (BRE-06016-1) was placed on all stock in inventory. DONE 2) Current customers of LX and DxC will be informed of the limitation for the use of fluid type 'Other' when programmed in combination with automatic or manual ORDAC for a GLUCm. IN PROCESS 3) New customers will receive reworked new instrument shipments with documentation regarding the use of fluid type 'Other' when programmed in combination with automatic or manual ORDAC for GLUCm. IN PROCESS 4) A Technical Update is being created to notify worldwide services of the PCA. IN PROCESS *Submit initial corrections and removal report. DONE *Under Investigation. IN PROCESS *Failure analysis is ongoing and preventative actions will be determined based on the investigation results. IN PROCESS *In Process. A 75% effectivity is targeted based the class II level of action required per the Beckman Coulter Product Corrective Action Subcommittee review. Each user will be contacted initially and then once more (if needed) in order to determine the rate of response from the Response form provided. This check enables us to ensure that users have received the PCA letter. Records will be maintained of each official contact, and may be made available upon request.
Quantity in commerce: 394 (361 in US & 33 in Canada)
Distribution: Nationwide, also Canada, France, Germany, Switzerland, UK, Spain, Belgium, Italy, Netherlands, Sweden, Czech Republic and other countries within Europoe, So. Africa, Isreal Kuwait, united Arab Emirates, Mexico, Argentina, Japan, Australia, Hong Kong, China, Taiwan, Korea, Asia, Africa and the Middle East. Note: According to the firm Customer lists for countires outside North America are maintained by regional offices. If necessary, requests can be made to gather the complete lists.
Product codes and lots: Software Version 1.0 and 1.2

Product code JJE

K042291Class IIUnicel Dxc 600 and 800 Synchron SystemsBeckman Coulter, Inc. / cleared 2004-11-12

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)