Phadia US Inc: Medical Device Recall in 2017 - (Recall #: Z-1253-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 30, 2017

Date Posted: March 8, 2017

Recall Number: Z-1253-2017

Event ID: 76343

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.

Status: Terminated

Product Quantity: 5957

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

Voluntary or Mandated:

Voluntary: Firm initiated