FDA Device recall Z-1253-2017
EliA Sample Diluent, Article number, 83-1023-01
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of EliA Sample Diluent, Article number, 83-1023-01 by Phadia Us, citing erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems wi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1253-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-30 |
| Published | 2017-03-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Phadia Us |
| Distribution | AR, CA, CO, FL, GA, IL, IN, KY, LA, MI, MN, MO, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WI, WV |
Product
EliA Sample Diluent, Article number, 83-1023-01
Reason
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.
Identifiers
| code_info | EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1253-2017%22
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