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VITROS recallZ-1288-2019 · Ortho-Clinical Diagnostics · initiated Feb 20, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ortho-Clinical Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems

FDA root cause category: Software design

What the company is doing

Ortho Clinical Diagnostics (Ortho) issued an "URGENT PRODUCT CORRECTION NOTIFICATION" , a customer letter (Ref. CL2019-052) dated 21 February 2019 via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to customers who were shipped affected VITROS Systems/or whose VITROS System has a luminometer parts replacement. The customers were notified of the issue and instructed to notify Ortho upon experiencing the issue described: -Avoid performing a shutdown/restart on your systems unless directed by an Ortho representative or prompted by condition code help text. -If you shutdown/restart and encounter any of the above Luminometer condition codes and are unable to process MicroWell assays, immediately contact the Ortho Care" Technical Solutions Center for service to your system. -Complete the enclosed Confirmation of Receipt form no later than March 1, 2019 by Fax: 1.888.557.3759 or 1.585.453.4110 or e-Mail Address: [email protected]. -Please forward this notification if the product was distributed outside of your facility. Foreign affiliates were informed by email on 21 February 2019 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take. Questions contact Ortho Care" Technical Solutions Center at 1-800-421-3311.

Recall details

Recall number
Z-1288-2019
Status
Terminated
Initiated by the company
Feb 20, 2019
Recalling firm
Ortho-Clinical Diagnostics
Quantity
4 units
Product code
JJE
FDA submissions
K081543
Distribution
Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom.

Product description

VITROS 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

Code information (models, lots, serial numbers)

Serial Numbers: Affects systems that had the Luminometer replaced during a service-repair UDI: 10758750007110

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 82311).

Sources and updates

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