PlainRecordsFDA · Medical device recall
VITROS Chemistry Products TP Slides- IVD measure total protein (TP)… and 1 more product
- Date
- Jan. 20, 2021
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Ortho Clinical Diagnostics Inc
- Reason
- Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
- Distribution pattern
- Worldwide distribution - US Nationwide distribution and the countries of AR, AU, BM, BR, CA, CL, CN, CO, CR, DO, EC, FR, FR, GT, HT, IN, JP, MX, PA, PE, PR, PY, SV.
2 products in this recall
VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using…
- Product
- VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292
- Quantity
- US= 223,788 ; OUS:=168,120 Totlal: 491,908
- Codes and lots
- All Current, Future and Past Lots UDI: 10758750004850
- Recall started
- Dec. 15, 2020
- Device type
- Biuret (Colorimetric), Total Protein
- Root cause (FDA)
- Device Design
- What the company told customers
- Ortho-Clinical Diagnostics (Ortho) issued customer letter (Ref. CL2018-308) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) on 15 Dec 2020 to all customers who received one of the affected products in the previous 18 months. Letter states reason for recall, health risk and action to take: Complete the enclosed Confirmation of Receipt form no later than insert date. Please provide the enclosed communication to customers who were shipped the affected products (listed above) from your facility within the last 18 months. Ortho has communicated with your customers that received drop shop product from our warehouse. Foreign affiliates were informed by email on 15 Dec 2020 of the issue and instructed to notify their consignees of the issue and their required action until the updated the IFU is available.
- Recall number
- Z-0844-2021
VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected)…
- Product
- VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293
- Quantity
- US=9802; OUS: 1298 Total: 11,100
- Codes and lots
- All Current, Future and Past Lots UDI: 10758750031771
- Recall started
- Dec. 15, 2020
- Device type
- Biuret (Colorimetric), Total Protein
- Root cause (FDA)
- Device Design
- What the company told customers
- Ortho-Clinical Diagnostics (Ortho) issued customer letter (Ref. CL2018-308) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) on 15 Dec 2020 to all customers who received one of the affected products in the previous 18 months. Letter states reason for recall, health risk and action to take: Complete the enclosed Confirmation of Receipt form no later than insert date. Please provide the enclosed communication to customers who were shipped the affected products (listed above) from your facility within the last 18 months. Ortho has communicated with your customers that received drop shop product from our warehouse. Foreign affiliates were informed by email on 15 Dec 2020 of the issue and instructed to notify their consignees of the issue and their required action until the updated the IFU is available.
- Recall number
- Z-0845-2021
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0844-2021, Z-0845-2021. The agency record governs; check it and the company before acting.