FDA Devices recall · Reported January 1, 2020
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.
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…
Ortho Clinical Diagnostics Inc recalled 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute s… - a moderate-severity action.
7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute s… was recalled by Ortho Clinical Diagnostics Inc in January 1, 2020. Reason: Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electroly…. Check the official notice for the remedy. Verify recall #Z-0739-2020 with the FDA Devices before acting.
The recall
Ortho Clinical Diagnostics Inc issued this moderate-severity FDA Devices recall-Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electroly….
- Moderate
- severity level
- 17K units
- affected scope
- Class II
- classification
- January 1, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0739-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0739-2020 |
| Date reported | January 1, 2020 |
| Date initiated | October 14, 2019 |
| Recalling firm | Ortho Clinical Diagnostics Inc |
| Firm location | Raritan, NJ |
| Affected scope | 16,584 |
| Distribution | Worldwide distribution - US Nationwide distribution and countries BM, AU, BR, CA, CL, CN, CO, IN, JP, MX, SG, GB, FR, DE, IT, ES, PT, PL, RU, DK, NO, SE, BE, NL. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0739-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
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Methodology · Corrections · Archive as of August 2026