Z-2344-2018 Class II Terminated
FDA device recall Z-2344-2018 was initiated by Ortho-Clinical Diagnostics on May 9, 2018 and is designated Class II. Reason for recall: There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control… The recall status is terminated (terminated Aug 18, 2020). Affected quantity: 5712.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 11, 2018
- Initiation Date
- May 9, 2018
- Termination Date
- Aug 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5712
Product Description
VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Reason for Recall
There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.
Distribution Pattern
Worldwide distribution. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, and Sweden
Code Information
Lot Numbers: 2616-0165-4866, 2616-0165-4904, 2616-0165-4870, 2616-0165-4869, 2616-0165-5266, 2616-0165-5307, 2616-0165-5233, 2616-0165-5232, 2616-0165-5611, 2616-0165-5610, 2616-0165-5648, 2616-0165-5649, 2616-0165-6218, 2616-0165-6275, 2616-0165-6220, 2616-0165-6221, 2616-0165-6219, 2616-0165-6276, 2616-0165-6791, 2616-0165-6832, 2616-0165-6792, 2616-0165-6787, 2616-0165-7225, 2616-0165-7226, 2616-0165-7223, 2616-0165-7214, 2616-0165-7222
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2344-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026