Recall Z-0992-2019 ยท JGS Electrode, Ion Specific, Sodium
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.
| Date | Jan 22, 2019 |
| Status | Terminated |
| 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 repl |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081411 | VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 Ortho-Clinical Diagnostics, Inc., Jun 30, 2008 |