Z-2874-2020Class II

VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides...

Name: Z-2874-2020 VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides...
Creator: Ortho-Clinical Diagnostics
Published: 2020-07-13
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2020-07-13 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu)... on 2020-07-13. FDA classified it as Class II and gives the reason as "Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2874-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-13
Posted: 2020-08-24
Terminated: 2021-07-27
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)
Product code: CIG Diazo Colorimetry, Bilirubin
Reason for recall: Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
FDA root cause: Other
Action: 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
Quantity in commerce: 80351:US=35113; OUS: OUS=1593941.1612365: US=20068; OUS= 35534
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.
Product codes and lots: All Current, Future and Past Lots UDI: 10758750004829, 10758750009398

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2874-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2873-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-24
Z-2874-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-24
Z-2875-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-24

Product code CIG

K840606Class IIEktachem Clinical Chem. SlidesEastman Kodak Company / cleared 1984-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)