Z-1476-2024Class II

ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20

Name: Z-1476-2024 ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20
Creator: Abbott Laboratories
Published: 2024-02-21
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-02-21 / Open, Classified / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20 on 2024-02-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1476-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-21
Posted: 2024-04-04
Recalling firm: Abbott Medical
Product: ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Product code: DDR Myoglobin, Antigen, Antiserum, Control
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued letters dated 2/21/2024 on the same date via FedEx Priority Overnight Express. The letter explained the reason for recall, the impact on patient results, and the necessary actions to be taken by the customer. Those actions included immediately discontinuing the use of and destroy any remaining inventory of the affected lots according to the consignee's laboratory procedures; review the letter with the Medical Director or Laboratory Management and follow the laboratory protocol regarding the need for reviewing previously reported results generated with lot 50808UN23; immediately contact Customer Support for replacement material; complete and return the Customer Reply Form; and if the product has been forwarded to other laboratories, they are to be informed of the recall with a copy of this letter provided to them. The Customer Reply Form was to be returned to the recalling firm prior to 06MAR2024.
Quantity in commerce: 7482 kits
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1476-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1476-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-04

Product code DDR

K042924Class IIArchitect Stat Myo ImmunoassayFisher Diagnostics / cleared 2005-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)