Z-0476-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2018
- Initiation Date
- October 8, 2018
- Termination Date
- October 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5850 units
Product Description
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
Reason for Recall
VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
Distribution Pattern
Nationwide Foreign: Australia Belgium Bermuda, HM11 Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Poland Portugal Russia Singapore Spain Sweden The Netherlands United Kingdom
Code Information
Lot Numbers: 1517-26-6396 (expires 6-Nov-2018) 1517-26-6582 (expires 2-Feb-2019) 1517-26-6639 (expires 2-Feb-2019) 1517-27-6808 (expires 7-May-2019)