—#90668

Product

GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800, UniCel DxC 800 PRO, UniCel DxC 880i, UniCel DxC 680i, UniCel DxC 660i, and UniCel DxC860i ),

FDA product code: CGA — Glucose Oxidase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K011213, K023049, K042291, K060256, K965240
Affected lot / code info: All non-expired lots are affected by the recall.

Why it was recalled

UniCel DxC and Synchron LX instruments produced inaccurate (low) GLUCm results. False low results could affect or delay diagnosis or treatment.

Root cause (FDA determination)

Other

Action the firm took

Beckman Coulter issued an "Urgent: Product Corrective Action" (PCA) letter dated April 2010 to all consignees, identifying the reason for the recall, the affected lots, and the potential for inaccurate GLUCm results due to bubble retention and short samples. Customers were instructed to: 1) establish specific protocols for samples from defined patient populations or sample types, which could include running specimens using GLUCm in duplicate or using cartridge glucose. 2) To reduce the possibility of inaccurate results, ensure that all elements are properly installed and secured, the sample probe is adequately tightened, and proper sample volume and integrity are maintained. A copy of the PCA letter will also be included in all new instrument ship kits. Consignees were instructed to complete and return an enclosed response form. Consignees can contact Beckman Coulter at 1-973-956-5300 .

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: Worldwide Distribution: USA and Canada

Timeline

Recall initiated: 2010-04-15
Posted by FDA: 2010-09-09
Terminated: 2013-12-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90668. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.