—#170972

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.

FDA product code: JGS — Electrode, Ion Specific, Sodium
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K081411
Affected lot / code info: Lot 4221-0998-3223

Why it was recalled

Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-01-22
Terminated: 2022-06-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170972. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.