FDA Enforcement
Class II
Terminated
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
Recall: Z-0476-2019
·
Reported November 28, 2018
Enforcement
- Recall Number
- Z-0476-2019
- Event ID
- 81376
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ortho-Clinical Diagnostics
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 28, 2018
- Initiation Date
- October 8, 2018
- Classification Date
- November 16, 2018
- Termination Date
- October 13, 2022
- Address
- 100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States
Description
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
Reason
VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
Code Info
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)
Distribution
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
Quantity
5850 units