Z-1671-2014Class II

ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane...

Name: Z-1671-2014 ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane...
Creator: Abbott Laboratories
Published: 2014-02-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-02-12 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer... on 2014-02-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1671-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-12
Posted: 2014-05-29
Terminated: 2015-05-22
Recalling firm: Abbott Medical
Product: 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: 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.
Product code: JIT Calibrator, Secondary
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
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Product Information letters dated August 23, 2013 were sent to all direct accounts alerting the direct accounts to a positive bias observed in test results using some of the affected kits. The letter advised the direct accounts to take this information into account when interpreting patient results. Customers with questions were advised to contact Customer Service at 877-4ABBOTT (877-422-2688) (24 hours a day, 7 days a week) and to refer to Product Information Letter PI23AUG2013. Product Recall letters dated February 12, 2014 were sent to all direct accounts. The letter included instructions to: 1) immediately discontinue the use of, and destroy, any remaining inventory of ARCHITECT Intact PTH assay according to each customer's laboratory practices; 2) to continue Intact PTH testing at your laboratory, Abbott recommends that customers identify an alternate method for testing patient samples; 3) if further guidance is needed, please contact the customers's Abbott sales representative; 4) review the letter with the treating physician or healthcare provider to ensure they are aware of the issue and can determine whether re-evaluation of the patient is necessary, and that Abbott included a physician letter that you can use to notify your ordering physicians of this issue; 5) If the customer forwarded any product to other laboratories, please inform them of this Product Recall and provide a copy of the recall letter, customer reply, and physician letter to them; and, 6) complete and return the Customer Reply. Customers with questions were advised to contact Customer Service at 877-4ABBOTT (877-422-2688) (24 hours a day, 7 days a week).
Quantity in commerce: 7,780 calibrator kits
Distribution: 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
Product codes and lots: List Number: 8K25-01. Lot Numbers and Expiration Dates: Lot 00613I000, Expires 05 SEP 2014; Lot 01913C000, Expires 14 MAR 2014; Lot 01913K000, Expires 12 NOV 2014; Lot 02413E000, Expires 09 MAY 2014; Lot 01312K000, Expires 12 NOV 2013; Lot 00813A000, Expires 08 JAN 2014; Lot 01412H000, Expires 16 AUG 2013; Lot 00912F000, Expires 30 MAY 2013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1671-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1671-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-04	2014-05-29
Z-1672-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-04	2014-05-29

Product code JIT

K063232Class IIArchitect Intact Pth Reagents, Calibrators (a-F) and Controls (Low, Medium, High), Models 8K25-20, 8K25-25, 8K25-01Biokit, S.A. / cleared 2007-06-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)