Z-0739-2020Class II

7% BSA (Bovine Serum Albumin)

Name: Z-0739-2020 7% BSA (Bovine Serum Albumin)
Creator: Ortho Clinical Diagnostics Inc
Published: 2019-10-14
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2019-10-14 / Terminated / root cause: design

FDA source

Ortho Clinical Diagnostics Inc began a recall of 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using... on 2019-10-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0739-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-14
Posted: 2019-12-26
Terminated: 2020-11-13
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: DCF Albumin, Antigen, Antiserum, Control
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
Root cause tag: design
FDA root cause: Device Design
Action: On August 9, 2019 the firm distributed Urgent Medical Device Recall Communication letters by via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) summarizing the reason as Ortho Clinical Diagnostics determined that VITROS 7% BSA and VITROS Urine Electrolyte Diluent (UED) do not meet the current OAS time of d 7 days when stored on the VITROS 250/350 System in a 2mL cup only. Orthos internal testing compared results from samples diluted with diluent stored on the analyzer versus fresh diluent. When using 7% BSA or UED stored in a 2mL cup for 7 days, the differences in the results vs fresh diluent were >10% for some assays. It explained as a resolution: " The OAS of 7% BSA and UED in 2mL cups has been revised to d24 hours. " Current OAS time remains at d7 days for storage in 5mL and 10 mL bottles. " The Instructions for Use and appropriate User Documentation will be revised at a future date. It instructs them to: - Send the enclosed customer letter to all customers to whom you shipped or know to have a VITROS 250/350 System. Please continue to provide this letter to new customers until the Instructions for Use are updated. - Complete and return the Confirmation of Receipt form by October 22, 2019.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0739-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0739-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-26
Z-0740-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-26

Product code DCF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)