Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
Lot # 2190, Product code(unique Device Identifier): 8430373 (10758750004898)
Products Sold
Lot # 2190; Product code(unique Device Identifier): 8430373 (10758750004898)
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack due to Lower than expected results for VITROS Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS Immunodiagnostic Products High Sample Dilue. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026