Reported Jan 1, 2020 · Terminated
7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values…
Ortho Clinical Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho Clinical Diagnostics Inc · 1001 US Highway 202 · Raritan, NJ · 08869-1424
Is this the product you have?
- 7% BSA (Bovine Serum Albumin)
- Product Code8262487 -
- Product Usageis 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
- Lot codes and dates
- Lot with Expiry Date
D62892019-11-20E63822020-01-15F66022020-05-02G66792020-08-13H68972020-10-01J71292021-01-23K74212021-07-01L75922021-08-26
- Lot with Expiry Date
- Amount recalled
- 16,584
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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