ARCHITECT recallZ-0971-2019 · Abbott Laboratories, Inc · initiated Jan 2, 2019

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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 [email protected]. 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.

Recall details

Recall number

Z-0971-2019

Status

Terminated

Initiated by the company

Jan 2, 2019

Recalling firm

Abbott Laboratories, Inc

Quantity

24,995 units

Product code

JGJ

FDA submissions

K981791

Distribution

Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR.

Product description

ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• ARCHITECT 7D70-21

  Abbott Laboratories · PHOTOMETRIC METHOD, MAGNESIUM
  1 recall37 reports
• ARCHITECT 7D70-31

  Abbott Laboratories · PHOTOMETRIC METHOD, MAGNESIUM
  1 recall16 reports

Product lines

• ARCHITECTAbbott Laboratories · 51 models · 5,426 reports · 11 recalls