Z-0844-2021Class II

VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using...

Name: Z-0844-2021 VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using...
Creator: Ortho Clinical Diagnostics Inc
Published: 2020-12-15
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2020-12-15 / Terminated / root cause: design

FDA source

Ortho Clinical Diagnostics Inc began a recall of 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... on 2020-12-15. FDA classified it as Class II and gives the reason as "Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0844-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-15
Posted: 2021-01-12
Terminated: 2021-07-27
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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
Product code: CEK Biuret (Colorimetric), Total Protein
Reason for recall: Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: US= 223,788 ; OUS:=168,120 Totlal: 491,908
Distribution: 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.
Product codes and lots: All Current, Future and Past Lots UDI: 10758750004850

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0844-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0844-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-12
Z-0845-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-12

Product code CEK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)