Recall Z-0739-2020
Ortho Clinical Diagnostics Inc · initiated October 14, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
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
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0739-2020
- Initiated
- October 14, 2019
- Terminated
- November 13, 2020
- Product code
- DCF – Albumin, Antigen, Antiserum, Control
- Quantity
- 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.
- Recalling firm
- Ortho Clinical Diagnostics Inc, Raritan, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0740-2020 Class II | Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine…Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine… | 10/14/2019Terminated |