Z-3184-2018 Class III Terminated
FDA device recall Z-3184-2018 was initiated by Ortho-Clinical Diagnostics on Jul 11, 2018 and is designated Class III. Reason for recall: The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples… The recall status is terminated (terminated Aug 11, 2020). Affected quantity: 168919.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 26, 2018
- Initiation Date
- Jul 11, 2018
- Termination Date
- Aug 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 168919
Product Description
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Reason for Recall
The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples when tested with the Cl- slide is not affected. The current Cl- LoQ is 5 mmol/L and the LoQ determined by this investigation is 15 mmol/L.
Distribution Pattern
Worldwide Distribution - US Nationwide- The products were distributed to the following foreign countries: 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 10 and above
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3184-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026