Z-1489-2021Class II

VITROS Black Reference Slides CATALOG #: J02316 -

Name: Z-1489-2021 VITROS Black Reference Slides CATALOG #: J02316 -
Creator: Ortho-Clinical Diagnostics, INc.
Published: 2021-03-26
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2021-03-26 / Terminated / root cause: labeling and UDI

FDA source

Ortho-Clinical Diagnostics, INc. began a recall of VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor... on 2021-03-26. FDA classified it as Class II and gives the reason as "Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpected color of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1489-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-26
Posted: 2021-04-23
Terminated: 2023-05-24
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
Product code: N/A
Reason for recall: Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpected color of the slides and tries to use Black Reference Slides as White Reference Slides, the Correction Factor test will fail - and the analyzer will not be able to produce results for any assays other than sodium, potassium, and chloride. If the customer doesnt have any White Reference Slides in reserve, they cant run the Correction Factor test correctly and get the analyzer running again until they get more White Reference Slides delivered. This could lead to a delay in results for all Vitros assays except for sodium, potassium, and chloride.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On 3/25/2021, Ortho Clinical Diagnostics issued an Urgent Medical Device Correction notice via letter notifying customers two lots of the VITROS Black Reference Slides have the incorrect part number on the box.
Quantity in commerce: 865 units of 25 slides each
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV, WY and the countries of Australia, Bermuda, Brazil, Canada, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands.
Product codes and lots: Lots: 9252-0058-3361, 9252-0058-3362

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1489-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1489-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-23

Product code N/A

K182063Class IIVITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc. / cleared 2018-10-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)