Recall Z-2552-2019— Sentinel CH SpA
Class II · Terminated
Class II FDA medical device recall by Sentinel CH SpA, initiated 2019-06-28, terminated 2020-07-24. It names one FDA 510(k) clearance: K070987. Product: Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320. Reason: Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results.
- Recalling firm
- Sentinel CH SpA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-28
- Terminated
- 2020-07-24
- Firm location
- Milan, Italy
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320
Reason for recall
Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results
Data sourced from openFDA. This site is unofficial and independent of the FDA.