VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
This recall has been terminated (originally issued July 13, 2020).
- Company
- Ortho-Clinical Diagnostics
- Recall Initiated
- July 13, 2020
- Terminated
- July 27, 2021
- Recall Number
- Z-2875-2020
- Quantity
- US= 4076 OUS=949
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
Reason for Recall
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda HM08, Brazil, Canada L3R 4G5, China, Denmark, France, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
Lot / Code Info
All Current, Future and Past Lots UDI: 10758750031801
Root Cause
Other
Action Taken
Ortho Clinical Diagnostics issued URGENT PRODUCT CORRECTION NOTIFICATION on 13 July 2020, customer letter (Ref. CL2018-181) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received one of the affected products in the previous 18 months. Foreign affiliates were informed by email on 13 July 2020 of the issue and instructed to notify their consignees of the issue and their required action until the updated the IFU is available. Letter states reason for recall, health risk and action to take: Instruction for Use will be update at a later date to indicate Eltrombopag as a known interferent. REQUIRED ACTIONS " Follow your normal laboratory procedures as you would for other known interferences." Complete the enclosed Confirmation of Receipt form no later than July 21, 2020. " Please forward this notification if the product was distributed outside of your facility. " Save this notification with your user documentation Questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311