Z-0992-2019 Class II Terminated
FDA device recall Z-0992-2019 was initiated by Ortho-Clinical Diagnostics on January 22, 2019 and is designated Class II. Reason for recall: Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results. The recall status is terminated (terminated June 10, 2022). Affected quantity: 1448.
Recall Details
- Product Type
- Devices
- Report Date
- March 20, 2019
- Initiation Date
- January 22, 2019
- Termination Date
- June 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1448
Product Description
VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Reason for Recall
Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
Distribution Pattern
US Distribution to states of: AL, CA, CT, FL, HI, IA, ID, IL, LA, MI, MO, MS, NC, NM, NY, OK, PA, TX, WV, and WY; and internationally to: Canada.
Code Information
Lot 4221-0998-3223