—#150391

Product

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

FDA product code: KHP — Acid, Lactic, Enzymatic Method
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Lot: 31497UN14 Exp.: 17 Oct. 2016; Lot: 09353UNI15 Exp.: 12 Feb. 2017; Lot: 45216UN15 12 May 2017; Lot: 14596UN15 Exp.: 30 Jul. 2017; Lot: 37055UN15 Exp.: 12 Oct. 2017; Lot: 14782UN16 Exp.: 21 Apr. 2018

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: Nationwide and Worldwide Distribution.

Timeline

Recall initiated: 2016-10-11
Posted by FDA: 2016-11-09
Terminated: 2017-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150391. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.