Abbott Recalls Architect Lactic Acid Assay Due to Drug Interference
Abbott is recalling 26,837 kits of the ARCHITECT Lactic Acid assay because the drug N-Acetyl Cysteine causes negative interference with the reagent.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential diagnostic inaccuracy due to drug interference rather than direct physical injury or contamination.
Plain-English summary
Abbott Laboratories is recalling 26,837 kits of the ARCHITECT Lactic Acid assay (Part # 09D891T21). The product is used to measure lactic acid levels in human plasma. The recall was initiated because Abbott identified negative interference from the drug N-Acetyl Cysteine (NAC) when used with the ARCHITECT Lactic Acid reagent.
The affected lots are 31497UN14, 09353UNI15, 45216UN15, 14596UN15, 37055UN15, and 14782UN16. These products were distributed nationwide and worldwide. The recall is classified as Class II by the FDA.
Healthcare facilities and laboratories should stop using the affected kits and contact Abbott Laboratories for instructions on how to return the product.
The recalled product
- Product
- ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
- Manufacturer
- Abbott Laboratories
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distribution
Distributed nationwide across the United States.
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