Z-0379-2017Class II

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

Name: Z-0379-2017 ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in...
Creator: Abbott Laboratories
Published: 2016-10-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-10-11 / Terminated

FDA source

Abbott Laboratories began a recall of ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma on 2016-10-11. FDA classified it as Class II and gives the reason as "Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0379-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-11
Posted: 2016-11-09
Terminated: 2017-05-17
Recalling firm: Abbott Medical
Product: ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
Product code: KHP Acid, Lactic, Enzymatic Method
Reason for recall: Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 26, 837 kits
Distribution: Nationwide and Worldwide Distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0379-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0379-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-09

Product code KHP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)