Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 4, 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 the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.
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…
Abbott Laboratories recalled ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic pe… — a moderate-severity action.
ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic pe… was recalled by Abbott Laboratories in June 4, 2014. Reason: Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate…. Check the official notice for the remedy. Verify recall #Z-1672-2014 with the FDA Devices before acting.
The recall
Abbott Laboratories issued this moderate-severity FDA Devices recall — Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate….
- Moderate
- severity level
- Class II
- classification
- June 4, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1672-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1672-2014) was formally reported on June 4, 2014, with the manufacturer initiating the action on February 12, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Abbott Laboratories is listed as the recalling firm, operating out of Abbott Park, IL. Federal records list the affected scope as List Number 8K25-10: 9,463 control kits.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico; Algeria, Andorra, Angola, Argentina, Armenia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia & Herzego…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
List Number 8K25-10: 9,463 control kits
Related Recalls
6
6 from same agency
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1672-2014 |
| Date reported | June 4, 2014 |
| Date initiated | February 12, 2014 |
| Recalling firm | Abbott Laboratories |
| Firm location | Abbott Park, IL |
| Affected scope | List Number 8K25-10: 9,463 control 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… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1672-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Abbott Laboratories. Units affected: List Number 8K25-10: 9,463 control kits.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 4, 2014. Severity: Moderate. Recall number: Z-1672-2014.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1672-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported June 4, 2014.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.