Z-0268-2020Class II

VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides...

Name: Z-0268-2020 VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides...
Creator: Ortho-Clinical Diagnostics
Published: 2019-09-10
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2019-09-10 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form on 2019-09-10. FDA classified it as Class II and gives the reason as "Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge". 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-0268-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-10
Posted: 2019-11-01
Terminated: 2020-11-13
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
Product code: CGZ Electrode, Ion-Specific, Chloride
Reason for recall: Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On September 10, 2019, the firm distributed Urgent Product Correction Notification letters to affected customers. Customers were asked to take the following actions: "Complete and return the Confirmation of Receipt form. "If you experience a slide dispense issue, try to reposition the ABP by following the instructions in the enclosed Resolving Slide Dispense Issues document. Please place the instructions by each VITROS System in your facility that processes Microslides. "If you are unable to reposition the ABP, remove the affected cartridge and replace it with a new one. Complete and return the Request for Credit form as needed to receive credit for the slides remaining within affected and discarded cartridges. "Please forward this notification if the product was distributed outside of your facility. The firm will provide credit for the slides remaining within affected cartridge for which you are unable to reposition the ABP. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 1365545 total
Distribution: Domestic distribution nationwide. Foreign distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, the Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.
Product codes and lots: 400506564305 400506564331 400506565287 400506575299 400506575361 400506635353 400506758400 400506728360 400506788811 400506758797 400506758798 400506789422 400506789423 400506809507 400506809508 400506820116 400506895392 400506895393 400506895394

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0268-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0267-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-01
Z-0268-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-01
Z-0269-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-01

Product code CGZ

K071801Class IIVitros Chemistry Products Ci-Slides, Calibrator Kit 2, Model(s) 844-5207, 166-2659Ortho-Clinical Diagnostics, Inc. / cleared 2007-07-20

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)