Z-0848-2019 Class II Terminated
FDA device recall Z-0848-2019 was initiated by Ortho-Clinical Diagnostics on Dec 11, 2018 and is designated Class II. Reason for recall: Negative bias results when using VITROS VALP Reagent, GEN 25. The recall status is terminated (terminated Sep 16, 2020). Affected quantity: 9014 Total (U.S. = 6798; OUS: U.S. = 2216).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 27, 2019
- Initiation Date
- Dec 11, 2018
- Termination Date
- Sep 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9014 Total (U.S. = 6798; OUS: U.S. = 2216)
Product Description
VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.
Reason for Recall
Negative bias results when using VITROS VALP Reagent, GEN 25.
Distribution Pattern
Worldwide distribution- US (Nationwide) and countries of: Australia, Belgium, Bermuda, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands and United Kingdom.
Code Information
Affected Lots/Expiry: 25-5263 2017-09-09; 25-5503 2018-01-06; 25-5727 2018-04-30; 25-5974 2018-08-14; 25-6067 2018-11-05; 25-6393 2019-04-05 (only non expired lot) Unique Identifier:10758750006748
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0848-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026