CLASS II ONGOING Device recall · Reported 10 Apr 2024 · FDA Enforcement Report
Architect Stat Myoglobin Reagent Kit, LN 2K43-25 and 2K43 recalled
Abbott Laboratories is recalling Architect Stat Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20, distributed nationwide in the US. The recall was initiated on 21 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1476-2024
- FDA event ID
- 94149
- Recalling firm
- Abbott Laboratories, Abbott Park, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Feb 2024
- FDA classified
- 4 Apr 2024
- Reported
- 10 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Test Kits & Diagnostics
Timeline
| 21 Feb 2024 | Recall initiated by company | |
| 4 Apr 2024 | Classified by FDA | +43 days |
| 10 Apr 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Where it was distributed
Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IL, KS, LA, MI, MO, MS, NE, NY, OH, OR, PA, TX, VA, and WI. The countries of Angola, Austria, Belarus, Belgium, Brazil, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Luxembourg, Mali, Mexico, Morocco, Poland, Portugal, Peoples Republic of China, Romania, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Switzerland, Taiwan, Tajikistan, Tanzania, Trinidad & Tobago, Turkey, Uganda, Uruguay, Uzbekistan, and Vietnam.
Nationwide AlabamaArkansasArizonaCaliforniaFloridaGeorgiaIllinoisKansasLouisianaMichiganMissouriMississippiNebraskaNew YorkOhioOregonPennsylvaniaTexasVirginiaWisconsin
Questions about this recall
Is Architect Stat Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20 recalled?
Yes. Abbott Laboratories recalled Architect Stat Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20 on 21 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1476-2024.
Why was it recalled?
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.
Which lots are affected?
LN 2K43-25 - Lot number 50808UN23, exp. 11/30/2024, UDI (01)00380740003302 (17)241130(10)50808UN23; LN 2K43-20 - Lot number 60104UN23, exp. 11/30/2024, UDI (01)00380740003296 (17)241130(10)60104UN23.
Where was it sold?
Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IL, KS, LA, MI, MO, MS, NE, NY, OH, OR, PA, TX, VA, and WI. The countries of Angola, Austria, Belarus, Belgium, Brazil, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Luxembourg, Mali, Mexico, Morocco, Poland, Portugal, Peoples Republic of China, Romania, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Switzerland, Taiwan, Tajikistan, Tanzania, Trinidad & Tobago, Turkey, Uganda, Uruguay, Uzbekistan, and Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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