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

FDA device recall Z-1476-2024 · posted 2024-04-04 · Open, Classified

Recall details

Recalling firm

Abbott Laboratories

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

DDR

Quantity affected

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,

Date initiated

2024-02-21

Date posted

2024-04-04

Location

Abbott Park, IL

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