EliA Sample Diluent — Class II medical device recall Z-1253-2017
Terminated recall by Phadia US Inc, reported 2017-03-08, distributed in AR, CA, CO, FL, GA, IL, IN, KY…. Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 25
| Recall number | Z-1253-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Phadia US Inc, Portage, MI, United States |
| Recall initiated | 2017-01-30 |
| Classified | 2017-02-24 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2017-08-07 |
| Distributed | AR, CA, CO, FL, GA, IL, IN, KY, LA, MI, MN, MO, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, WI, WV |
| Quantity | 5,957 |
| Lot numbers | JK5N, JM3Y, JP87, JS0B, JU9C |
Product
EliA Sample Diluent, Article number, 83-1023-01
Reason for recall
Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the liquid level detection in diluent bottle batch JJCA resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate.
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-1253-2017. 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.