Z-3043-2018 Class III Terminated
FDA device recall Z-3043-2018 was initiated by Ortho-Clinical Diagnostics on Jul 11, 2018 and is designated Class III. Reason for recall: The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a… The recall status is terminated (terminated Aug 11, 2020). Affected quantity: 128196.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 19, 2018
- Initiation Date
- Jul 11, 2018
- Termination Date
- Aug 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 128196
Product Description
VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Reason for Recall
The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.
Distribution Pattern
Worldwide Distribution - US Nationwide and in the countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.
Code Information
GEN 5 and below
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3043-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026