FDA Device recall Z-1672-2014
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 (bo…
- FDA Device
- Class II
- terminated
- Published 2014-06-04
On 2014-06-04 the FDA classified a Class II recall of 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 (bo… by Abbott Laboratories, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1672-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-12 |
| Published | 2014-06-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
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
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
Identifiers
| code_info | List Number: 8K25-10. Lot Numbers and Expiration Dates: Lot 00713I000, Expires 05 SEP 2014; Lot 01813C000, Expires 14 M…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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1672-2014%22
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