FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
- Recall number
- Z-0992-2019
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
- Status
- Terminated
- Initiated
- 2019-01-22
- Posted
- not on file
- Terminated
- 2022-06-10
- Reason
- Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
- Root cause
- Under Investigation by firm
- Action
- The firm, Ortho Clinical Diagnostics, sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letters dated 1/22/19 to is customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " If you have an alternate lot of VITROS Na+ Slides, discontinue using and discard all remaining inventory of Lot 4221-0998-3223. " If you do NOT have an alternate lot, consult with your medical or laboratory director to determine if it is acceptable to continue using the affected lot until your replacement order arrives. " Until you receive your replacement order: o Performing Osmolality calculations on your VITROS System is not recommended. o If you continue using the affected lot, it is strongly recommended to take additional action to detect imprecision, such as performing duplicate testing for each sample. Repeat testing if there is a discrepancy between the results obtained in duplicate testing (i.e., +/- 1.4 mmol/L). o Discard all remaining inventory when your replacement order arrives. An adequate supply of replacement product is available and Ortho will expedite all replacement orders. " Please complete the enclosed Confirmation of Receipt form by e-Mail to RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM or Fax to: 1.888.557.3759 or 1.585.453.4110. Ortho will credit your account or send a replacement order for the discarded slides. " Forward the information in this notification if you have distributed this product outside of your facility. If you have questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
- Quantity
- 1448
- Distribution
- US Distribution to states of: AL, CA, CT, FL, HI, IA, ID, IL, LA, MI, MO, MS, NC, NM, NY, OK, PA, TX, WV, and WY; and internationally to: Canada.
- Lot, serial or model codes
- Lot 4221-0998-3223
- 510(k) numbers
- ["K081411"]
- PMA numbers
- not on file
- Product code
- JGS
- 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