Z-0392-2019 Class II Terminated
FDA device recall Z-0392-2019 was initiated by Ortho-Clinical Diagnostics on Aug 28, 2018 and is designated Class II. Reason for recall: The reagent pack exhibits the potential for an increased frequency of calibration failures. The recall status is terminated (terminated Aug 11, 2020). Affected quantity: 6630.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 14, 2018
- Initiation Date
- Aug 28, 2018
- Termination Date
- Aug 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6630
Product Description
VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, to aid in the differential diagnosis of anemia
Reason for Recall
The reagent pack exhibits the potential for an increased frequency of calibration failures.
Distribution Pattern
Worldwide Distribution: US (nationwide) to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VT, WA, WI, WV, and WY; and countries of: Belgium, Bermuda, Brazil, Canada, Chile, Columbia, Denmark, France, Germany, India, Italy, Portugal, Spain, and UK.
Code Information
Lot 2601, 2610, 2620
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0392-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026