Vitros Eci Immunidiagnostic Products Tsh Reagent Pack, Prolactin Reagent Pack, Fsh Reagent Pack, Folate Reagent Pack 1/2, And Psa Reagent Pack (2018-07-13)
Ortho Clinical Diagnostics is recalling five VITROS reagent packs used in laboratory testing equipment across Canada because they may produce inaccurate test results due to a manufacturing issue. The affected products are used to measure TSH, Prolactin, FSH, Folate, and PSA levels in patient blood samples. This recall applies to all VITROS Eci reagent packs of these types distributed in Canada.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2018-08-17
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/cd365c04-e145-4e10-a86c-d3dffb148361