| Class 2 Device Recall Abbott ARCHITECT STAT Myoglobin Reagent Kit |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DDR
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