FDA Device recall Z-0739-2020
7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dy…
- FDA Device
- Class II
- terminated
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class II recall of 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dy… by Ortho Clinical Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0739-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-14 |
| Published | 2020-01-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
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
Identifiers
| code_info | Lot with Expiry Date: D6289 2019-11-20 E6382 2020-01-15 F6602 2020-05-02 G6679 2020-08-13 H6897 2020-10-01 J7129…Lot with Expiry Date: D6289 2019-11-20 E6382 2020-01-15 F6602 2020-05-02 G6679 2020-08-13 H6897 2020-10-01 J7129 2021-01-23 K7421 2021-07-01 L7592 2021-08-26 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0739-2020%22
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