Z-2142-2024 Class II Ongoing
FDA device recall Z-2142-2024 was initiated by Ortho-Clinical Diagnostics, Inc. on Mar 1, 2024 and is designated Class II. Reason for recall: Potential for positively biased results due to signal reduction over shelf life. The recall status is ongoing. Affected quantity: 481 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 19, 2024
- Initiation Date
- Mar 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 481 units
Product Description
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
Reason for Recall
Potential for positively biased results due to signal reduction over shelf life.
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WI, WV and the countries of Bermuda, Colombia, Singapore.
Code Information
Model No. 6801926; GTIN# 10758750001699; Lot 9010 (Manufactured 13-Oct-2023; Expiry 15-Jul-2024) and 9030 (Manufactured 09-Dec-2023; Expiry 26-Aug-2024).
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2142-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026