ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma

FDA device recall Z-0379-2017 · posted 2016-11-09 · Terminated

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).

Action taken

Abbott Laboratories sent an Product Correction Immediate Action Required letter dated October 10, 2016, to all affected customers. Please review this letter with your Medical Director Taking the above information into consideration, you may continue to use ARCHITECT Lactic Acid reagent (LN 9D89-21) Please complete and return the Customer Reply Form 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 Please retain this letter for your laboratory records. 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 1-877-4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service. For further questions please call (847) 937-2550.

Root cause

Under Investigation by firm

Status

Terminated

Product code

KHP

Quantity affected

26, 837 kits

Distribution

Nationwide and Worldwide Distribution.

Date initiated

2016-10-11

Date posted

2016-11-09

Date terminated

2017-05-17

Location

Abbott Park, IL