Recall Z-0971-2019

Reason for recall

Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias specification and demonstrate depressed recovery of up to 37%. The specific cause of the negative bias/depressed results is currently under investigation.

FDA-determined cause: Under Investigation by firm

Action taken

The firm, Abbott, initiated the recall by letter on 01/02/2018 titled '"Product Correction Urgent-Immediate Action Required" by its customers. The letter explained the issue, described the product and actions to be taken. The customers were instructed to do the following: -Immediately discontinue use of the ARCHITECT Magnesium (LN 7D70) urine application. - You may continue to use the serum/plasma application for the ARCHITECT Magnesium (LN 7D70). -Please review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported patient results. -Complete and return the Customer Reply Form prior to January 17, 2019 via FAX #: 18007770051 or email QAGCO@abbott.com. Even if you no longer have the instrument(s),. -If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. -As an alternative to the current urine application, you may use Abbott ARCHITECT (enzymatic) Magnesium LN 3P68, urine application, where available. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.