Z-0503-2022Class II

VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

Name: Z-0503-2022 VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2021-11-22
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2021-11-22 / Open, Classified

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack on 2021-11-22. FDA classified it as Class II and gives the reason as "Lower than expected results for VITROS Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0503-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-22
Posted: 2022-01-18
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Product code: PPM General Purpose Reagent
Reason for recall: Lower than expected results for VITROS Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.
FDA root cause: Under Investigation by firm
Action: Ortho clinical Diagnostics issued an Important product correction notification on November 22, 2021. Actions to be taken by the Distributors: 1. Please provide the communication (Ref. CL2021-287) to customers who were shipped VITROS HSDA Lot 2190 from your facility. 2. Do not continue to distribute VITROS HSDA Lot 2190. 3. Complete the Confirmation of Receipt form no later than November 30, 2021. 4. Please forward this notification if the product was distributed outside of your facility. If you have questions, please contact our Ortho Care" Technical Solutions Center at 1-800-421-3311. Action to be taken by the customers: 1. Discontinue using VITROS HSDA Lot 2190 if your laboratory utilizes VITROS TSH Reagent Pack. 2.Complete the Confirmation of Receipt form no later than November 30, 2021, even if no replacement product is required. If replacement is required, indicate the quantity of VITROS HSDA Lot 2190 to be replaced. 3. Please forward this notification if the product was distributed outside of your facility. Contact Information If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311
Quantity in commerce: 1416 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KY, LA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands.
Product codes and lots: Lot # 2190; Product code(unique Device Identifier): 8430373 (10758750004898)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0503-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0503-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-26	2022-01-18

Product code PPM

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