Z-0735-2022Class II

VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per...

Name: Z-0735-2022 VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2021-12-10
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2021-12-10 / Open, Classified / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box on 2021-12-10. FDA classified it as Class II and gives the reason as "The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0735-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-10
Posted: 2022-03-08
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Product code: JRC Micro Pipette
Reason for recall: The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On December 10, 2021, the firm notified consignees through ORTHO PLUSSM (a service that provides customers with Ortho Clinical Diagnostics product notifications electronically) of the product issue. Customers were instructed to discontinue use and discard the affected lot. Customers should forward the notification if the product was distributed outside of their facility.
Quantity in commerce: 4125 units
Distribution: Domestic distribution nationwide. Foreign distribution to Canada.
Product codes and lots: UDI 10758750006786 Lot 1039734

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0735-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0735-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-08

Product code JRC

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)