FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics, Inc.: VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
- Recall number
- Z-0503-2022
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Product
- VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
- Status
- Open, Classified
- Initiated
- 2021-11-22
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- Lot # 2190; Product code(unique Device Identifier): 8430373 (10758750004898)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PPM
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28