ICT Serum Calibrator REF 146-03 — Class II medical device recall Z-1932-2015
Terminated recall by Abbott Laboratories, reported 2015-07-08, distributed nationwide. ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on th
| Recall number | Z-1932-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2014-07-22 |
| Classified | 2015-06-27 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2015-07-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BM, BR, BS, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IT, JM, JO, KE, KR, KW, KY, LB, LT, LU, LV, MA, MX, MY, NL, NO, NZ, OM, PA, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, UY, VE, VN, ZA |
| Quantity | 11,215 units |
| Lot numbers | 21399UN13 |
| Model numbers | 146-03 |
| Expiration dates | 2014-08-05, 2014-11-12, 2014-12-08, 2015-01-14, 2015-02-04 |
Product
ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
Reason for recall
ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
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-1932-2015. 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.