FDA Medical Device Recalls (openFDA)
Abbott Laboratories: ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
- Recall number
- Z-0379-2017
- Recalling firm
- Abbott Laboratories
- Product
- ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
- Status
- Terminated
- Initiated
- 2016-10-11
- Posted
- 2016-11-09
- Terminated
- 2017-05-17
- Reason
- Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
- 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
- 26, 837 kits
- Distribution
- Nationwide and Worldwide Distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KHP
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28