Recall Z-2873-2020
Ortho-Clinical Diagnostics · initiated July 13, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931
Codes / lots: All Current, Future and Past Lots UDI: 10758750031801
Reason for recall
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
FDA-determined 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
Details
- Recall number
- Z-2873-2020
- Initiated
- July 13, 2020
- Terminated
- July 27, 2021
- Product code
- JFY – Enzymatic Method, Creatinine
- Quantity
- US= 149370 OUS=223069
- 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.
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2874-2020 Class II | VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry…Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT… | 07/13/2020Terminated |
| Z-2875-2020 Class II | VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic…Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT… | 07/13/2020Terminated |