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Recall Observatory FDA recall evidence

Device product

EliA Sample Diluent, Article number, 83-1023-01

Z-1253-2017

January 30, 2017

Class II

Product summary

Firm
Phadia US Inc
Event
Event 76343
Status
Terminated
Classification
Class II
Quantity
5957
Official record key
device-enforcement:Z-1253-2017

Official wording

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.

Code information: EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C

Distribution pattern: Domestic: 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 Foreign: None VA/DOD: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.