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Open, Classified

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

FDA Recall Z-0735-2022 · Posted None

Recalling FirmOrtho-Clinical Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeJRC
Date Initiated2021-12-10
Product Quantity4125 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Domestic distribution nationwide. Foreign distribution to Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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