Device Recall Unicel Synchron Clinical Systems 의 리콜

Recall

55163

Class 2

Z-2441-2010

2010-01-18

2010-09-20

Terminated

United States

2012-08-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90198

The recall was initiated due to " a loose aliquot probe tube fitting in the closed tube aliquotter (cta), may result in erroneous access immunoassay results or synchron chemistry results". this may result in dilution of the sample with wash buffer; patient results can potentially be affected for access immunoassays or synchron chemistries. access quality control may also be affected if run throug.

Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated January 18, 2010, to all affected customers. The letter provided the customer with an explanation of the problem identified, the affected product, and instructions for the customer. The letter requested customers complete the following actions for : (1) CTA Aliquot Probe Inspection and Maintenance: a. Check daily for signs of leaks or damage to the tube fitting by looking and feeling for liquid at the fitting, the end of the probe and the surrounding areas; b. The CTA Aliquot Probe tube fitting should be checked to ensure that it is connected tightly to the Aliquot Probe. Without loosening the tube fitting, ensure it is securely tightened; c. When replacing the CTA Aliquot Probe, ensure that the Aliquot Probe tube fitting is securely tightened, prime the CTA, inspect for leaks, and run Access Quality Control through the CTA; d. If a leaking Aliquot Probe is suspected, review all sample results for both Access and Synchron in light of the total clinical presentation of the patient including: symptoms, clinical history, data from additional tests, and other appropriate information; e. As this issue may result in dilution of the sample with Wash Buffer; it may be appropriate to discard and redraw any affected sample tubes run on the CTA. The letter also informed customers that Beckman Coulter is currently evaluating potential solutions for this issue and requested they share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they forwarded the affected products to another laboratory, they were asked to provide a copy of this letter to them. They were also instructed to complete and return the enclosed response form within 10 days. Customers were told to call Customer Technical Support Center (Hotline) at (800) 854-3633 in the United States and Canada with any questions.