ARCHITECT recallZ-1476-2024 · Abbott Laboratories · initiated Feb 21, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Laboratories or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1476-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 21, 2024
- Posted by the FDA
- Apr 4, 2024
- Recalling firm
- Abbott Laboratories
- Quantity
- 7482 kits
- Product code
- DDR
- FDA submissions
- K042924
- 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 description
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- ARCHITECT 2K43-25Abbott Ireland Diagnostics · CALIBRATOR, PRIMARY1 recall23 reports
- ARCHITECT 2K43-20Abbott Ireland Diagnostics · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL1 recall8 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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