Z-3280-2018Class II

VITROS Sodium Slides, Catalog # 837 9034

Name: Z-3280-2018 VITROS Sodium Slides, Catalog # 837 9034
Creator: Ortho-Clinical Diagnostics
Published: 2018-05-05
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2018-05-05 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Sodium Slides, Catalog # 837 9034 on 2018-05-05. FDA classified it as Class II and gives the reason as "Potential for positively biased results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3280-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-05
Posted: 2018-09-28
Terminated: 2021-02-19
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Sodium Slides, Catalog # 837 9034
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: Potential for positively biased results
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 05 May 2018, Customer letter (Ref. CL2018-123) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all VITROS customers, who have a analyzer capable of running VITROS Na+ slides, to inform them of the issue and to request that they immediately discontinue use of this VITROS Na+ Slides, GENs 8 and 13. Continued use of VITROS Na+ Slides, GENs14,16,17& 18 is acceptable provided the conditions detailed in the communication are met. Foreign affiliates were initially informed by email on 05 May 2018 of the issue and instructed to notify their consignees of the affected product with this issue and the requirement to immediately discontinue use of the VITROS Na+ slides GENs 8, 13, 14, 16, 17 and 18. Due to the amount of time required to ship replacement product to some worldwide locations, a revised communication to the foreign affiliates occurred on 08 June 2018. Due to the health risk associated with potentially leaving the laboratory without a Na+ method, the revised letter instructs customers that they may continue to use GENs 14, 16, 17 and 18 until replacement product is received.
Distribution: US Nationwide, Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium and the Netherlands
Product codes and lots: UDI - 10758750004812 GENs- 8, 13, 14, 16, 17 & 18 Expiry Dates: 01-Nov-2018 through 01-Nov-2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3280-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3280-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-09-28

Product code JGS

K924471Class IIKodak Ektachem Clinical Chemistry Slides (Nail)Eastman Kodak Company / cleared 1992-11-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)