Unicel Dxi 600, 800 Access Immunoassay Systems (thyroglobulin Antibody Ii, Free T3 Assay, Free T4 Assay, Total T3 Assay, Thyroglobulin Assay, Gi Monitor (ca 19-9))(2019-04-22)
Summary Beckman Coulter is recalling certain UniCel DxI immunoassay systems and their thyroid and cancer marker test assays across Canada because these devices may produce inaccurate test results. The affected systems include models 600 and 800, and the recall applies to several specific blood tests used to measure thyroid function and cancer markers. This recall impacts healthcare facilities and laboratories that use these devices for patient testing.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2019-05-17
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/13495203-56fa-4383-9366-b41529a2bcf2