Recall Z-2079-2019— Abbott Laboratories
Class III · Terminated
Class III FDA medical device recall by Abbott Laboratories, initiated 2019-05-24, terminated 2021-04-01. It names one FDA 510(k) clearance: K060964. Product: ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma.. Reason: Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing..
- Recalling firm
- Abbott Laboratories
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-05-24
- Terminated
- 2021-04-01
- Firm location
- Abbott Park, IL, 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
ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma.
Reason for recall
Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.