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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott ARCHITECT STAT Myoglobin Reagent Kit

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  Class 2 Device Recall Abbott ARCHITECT STAT Myoglobin Reagent Kit see related information
Date Initiated by Firm February 21, 2024
Date Posted April 04, 2024
Recall Status1 Open3, Classified
Recall Number Z-1476-2024
Recall Event ID 94149
510(K)Number K042924  
Product Classification Myoglobin, antigen, antiserum, control - Product Code DDR
Product ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Code Information 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.
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd Bldg Ap8b
Abbott Park IL 60064-3502
For Additional Information Contact Suchin Song
224-668-1188
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DDR and Original Applicant = FISHER DIAGNOSTICS
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