Recall Z-1074-2019— Abbott Laboratories
Class II · Terminated
Class II FDA medical device recall by Abbott Laboratories, initiated 2019-02-20, terminated 2021-08-13. It names one FDA 510(k) clearance: K081495. Product: CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.. Reason: There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT..
- Recalling firm
- Abbott Laboratories
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-02-20
- Terminated
- 2021-08-13
- Firm location
- Santa Clara, CA, United States
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
CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.
Reason for recall
There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
Data sourced from openFDA. This site is unofficial and independent of the FDA.