—#45230

Product

SYNCHRON LX i 725 Clinical Systems; Operating Software Version 4.5; Part Number: A23724

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K023049
Affected lot / code info: Software Version 4.5

Why it was recalled

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 version 4.5. 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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 4300 N Harbor Blvd, Fullerton, California 92835-1091

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2006-03-15
Posted by FDA: 2006-05-25
Terminated: 2012-04-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45230. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.