Recall Z-0739-2020— Ortho Clinical Diagnostics Inc
Class II · Terminated
Class II FDA medical device recall by Ortho Clinical Diagnostics Inc, initiated 2019-10-14, terminated 2020-11-13. FDA's recall record names no specific 510(k) clearance for this event. Product: 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.. Reason: Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days.
- Recalling firm
- Ortho Clinical Diagnostics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-14
- Terminated
- 2020-11-13
- Firm location
- Raritan, NJ, United States
Product description
7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
Reason for recall
Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days
Data sourced from openFDA. This site is unofficial and independent of the FDA.