Z-0379-2017 Class II Terminated
FDA device recall Z-0379-2017 was initiated by Abbott Laboratories on Oct 11, 2016 and is designated Class II. Reason for recall: Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21). The recall status is terminated (terminated May 17, 2017). Affected quantity: 26, 837 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 16, 2016
- Initiation Date
- Oct 11, 2016
- Termination Date
- May 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26, 837 kits
Product Description
ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
Reason for Recall
Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
Distribution Pattern
Nationwide and Worldwide Distribution.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0379-2017
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026