Device recall: ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer…
Class II FDA enforcement event 67527. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Abbott Laboratories started this device recall on 12 Feb 2014. The firm address in the FDA record is in Abbott Park, IL. FDA put the recall in Class II. FDA event 67527 has 2 product records. The first FDA enforcement report date is 4 Jun 2014. The record gives the status Terminated, with the termination date 22 May 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico; Algeria, Andorra, Angola, Argentina, Armenia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus,…
Recalling firm
Abbott Laboratories, Abbott Park, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1671-2014 | ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage:… | 7,780 calibrator kits | Class II | Terminated | 4 Jun 2014 |
| 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 (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for… | List Number 8K25-10: 9,463 control kits | Class II | Terminated | 4 Jun 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 46
Other events of the firm
Official channels
- FDA enforcement report Z-1671-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 67527. https://recallregister.com/fda/ii/67527/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico; Algeria, Andorra, Angola, Argentina, Armenia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus,…
- What quantity of product is in FDA event 67527?
- The event has 2 product records. The first record gives this quantity:
7,780 calibrator kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.