Z-0992-2019Class II

VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+...

Name: Z-0992-2019 VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+...
Creator: Ortho-Clinical Diagnostics
Published: 2019-01-22
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2019-01-22 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+)... on 2019-01-22. FDA classified it as Class II and gives the reason as "Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0992-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-22
Posted: 2019-03-09
Terminated: 2022-06-10
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
FDA 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 [email protected] 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 in commerce: 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.
Product codes and lots: Lot 4221-0998-3223

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0992-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0992-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-08

Product code JGS

K081411Class IIVitros Chemistry Product Na+ Slides; Vitros Chemistry Products Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. / cleared 2008-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)