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Terminated

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

FDA Recall Z-0844-2021 · Posted None

Recalling FirmOrtho Clinical Diagnostics Inc
Recall StatusTerminated
Product CodeCEK
Date Initiated2020-12-15
Date Terminated2021-07-27
Product QuantityUS= 223,788 ; OUS:=168,120 Totlal: 491,908

Reason for Recall

Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides

Firm Action

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.

Root Cause

Device Design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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