Home / Recalls / Abbott Laboratories / Z-1672-2014

Z-1672-2014 Class II Terminated

Recalled by Abbott Laboratories — Abbott Park, IL

FDA device recall Z-1672-2014 was initiated by Abbott Laboratories on Feb 12, 2014 and is designated Class II. Reason for recall: Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may… The recall status is terminated (terminated May 22, 2015). Affected quantity: List Number 8K25-10: 9,463 control kits.

Recall Details

Product Type: Devices
Report Date: Jun 4, 2014
Initiation Date: Feb 12, 2014
Termination Date: May 22, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: List Number 8K25-10: 9,463 control kits

Product Description

ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.

Reason for Recall

Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous calibrator and/or control lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT In

Distribution Pattern

Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico; Algeria, Andorra, Angola, Argentina, Armenia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gaza and Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, ITALY, Jamaica, Japan, Jordan, Kenya, Korea (South Korea), Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Panam¿, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, San Marino, Saudi, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, SPAIN, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Ukraine, Uruguay, Venezuela, Vietnam, and Yemen

Code Information

List Number: 8K25-10. Lot Numbers and Expiration Dates: Lot 00713I000, Expires 05 SEP 2014; Lot 01813C000, Expires 14 MAR 2014; Lot 01813K000, Expires 12 NOV 2014; Lot 02613E000, Expires 09 MAY 2014; Lot 01412K000, Expires 12 NOV 2013; Lot 00713A000, Expires 08 JAN 2014; Lot 01012F000, Expires 30 MAY 2013.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1672-2014
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Abbott Laboratories

Z-0961-2026 Class II — Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 (Nov 13, 2025)
Z-0489-2026 Class II — Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer… (Sep 18, 2025)
Z-1652-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number… (Mar 18, 2025)
Z-1656-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number… (Mar 18, 2025)
Z-1655-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number… (Mar 18, 2025)
Z-1654-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number… (Mar 18, 2025)
Z-1653-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number… (Mar 18, 2025)
Z-2681-2024 Class II — Alinity hq Analyzer, REF: 09P68-01 (Jun 14, 2024)
Z-1476-2024 Class II — ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. (Feb 21, 2024)
F-0328-2024 Class II — Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil… (Oct 31, 2023)