Recall Z-1476-2024— Abbott Laboratories
Class II · Ongoing
Class II FDA medical device recall by Abbott Laboratories, initiated 2024-02-21. It names one FDA 510(k) clearance: K042924. Product: ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.. Reason: The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction..
- Recalling firm
- Abbott Laboratories
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-21
- 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 STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Reason for recall
The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.
Data sourced from openFDA. This site is unofficial and independent of the FDA.