ARCHITECT Intact PTH Calibrators consists of 6 bottles — Class II medical device recall Z-1671-2014
Terminated recall by Abbott Laboratories, reported 2014-06-04, distributed nationwide. Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate
| Recall number | Z-1671-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2014-02-12 |
| Classified | 2014-05-29 |
| Reported by FDA | 2014-06-04 |
| Terminated | 2015-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BB, BD, BE, BG, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KE, KR, KW, KY, LB, LK, LT, LU, LV, MA, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 7,780 calibrator |
| Reason classes | potency |
| Lot numbers | 00613I000, 00813A000, 00912F000, 01312K000, 01412H000, 01913C000, 01913K000, 02413E000 |
| Expiration dates | 2013-05-30, 2013-08-16, 2013-11-12, 2014-01-08, 2014-03-14, 2014-05-09, 2014-09-05, 2014-11-12 |
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1671-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.