Z-0915-2018 Class II Terminated
FDA device recall Z-0915-2018 was initiated by Ortho-Clinical Diagnostics on September 22, 2017 and is designated Class II. Reason for recall: This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control. The recall status is terminated (terminated August 24, 2020). Affected quantity: 102.
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- September 22, 2017
- Termination Date
- August 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102
Product Description
VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
Reason for Recall
This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.
Distribution Pattern
Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.
Code Information
Catalog# 6802331 Lot# M5620