Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYS. - DAT PERFORMANCE VERIFIERS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78604
  • Event Risk Class
    III
  • Event Initiated Date
    2017-09-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Ortho clinical diagnostics has initiated this recall due to the potential to obtain lower than expected quality control (qc) results for vitros benz reagent using specific lots of vitros dat performance verifiers. if the issue occurs qc results for benz may be at or below ortho's range of means as defined in the assay sheets. this issue may lead to an inability to verify calibration or cause failures in daily qc results.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYS. - DAT PERFORMANCE VERIFIERS
  • Model / Serial
    Model Catalog: 680 2328 (Lot serial: M5620); Model Catalog: 680 2329 (Lot serial: M5620); Model Catalog: 680 2331 (Lot serial: L5619); Model Catalog: 680 2330 (Lot serial: L5619); Model Catalog: 680 2329 (Lot serial: L5619); Model Catalog: 680 2328 (Lot serial: L5619); Model Catalog: 680 2327 (Lot serial: L5619); Model Catalog: 680 2331 (Lot serial: K5618); Model Catalog: 680 2330 (Lot serial: K5618); Model Catalog: 680 2329 (Lot serial: K5618); Model Catalog: 680 2328 (Lot serial: K5618); Model Catalog: 680 2327 (Lot serial: K5618); Model Catalog: 680 2331 (Lot serial: J5617); Model Catalog: 680 2330 (Lot serial: J5617); Model Catalog: 680 2329 (Lot serial: J5617); Model Catalog: 680 2328 (Lot serial: J5617); Model Catalog: 680 2327 (Lot serial: J5617); Model Catalog: 680 2331 (Lot serial: H5616); Model Catalog: 680 2330 (Lot serial: H5616); Model Catalog: 680 2329 (Lot serial: H5616); Model Catalog: 680 2328 (Lot serial: H5616); Model Catalog: 680 2327 (Lot serial: H5616); Model Catalog: 680 2331 (Lot seri
  • Product Description
    VITROS CHEMISTRY PRODUCTS 5 1 FS CHEMISTRY SYST
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS