Z-2962-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2020
- Initiation Date
- August 11, 2020
- Termination Date
- October 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21
Product Description
Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.
Reason for Recall
An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the technical bulletin. Interference to the Lactate Dehydrogenase (LOH) reagent would be observed as inconsistencies in Quality Control recovery, which may lead to a delay in running patient samples, or erroneous elevated test results.
Distribution Pattern
US Nationwide distribution including in the states of WV, and Puerto Rico.
Code Information
GTIN: 05055273204124; Lot Numbers: 480483 495947 523902 536342