EliA Sample Diluent, Article number, 83-1023-01
Reported: March 8, 2017 Initiated: January 30, 2017 #Z-1253-2017
Product Description
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.
Details
- Recalling Firm
- Phadia US Inc
- Units Affected
- 5957
- Distribution
- 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
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
EliA Sample Diluent, Article number, 83-1023-01. Recalled by Phadia US Inc. Units affected: 5957.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 8, 2017. Severity: Moderate. Recall number: Z-1253-2017.
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