Recall Z-1476-2024 ยท DDR Myoglobin, Antigen, Antiserum, Control
Abbott Laboratories
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
| Date | Apr 4, 2024 (initiated Feb 21, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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; |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042924 | ARCHITECT STAT MYO IMMUNOASSAY Fisher Diagnostics, Jan 24, 2005 |