Device product
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).
Z-2142-2024
Product summary
- Event
- Event 94679
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 481 units
- Official record key
device-enforcement:Z-2142-2024
Official wording
Reason: Potential for positively biased results due to signal reduction over shelf life.
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).
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.
Derived failure modes
-
Unknown
Potential for positively biased results due to signal reduction over shelf life.