Z-1253-2017Class II

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

Name: Z-1253-2017 EliA Sample Diluent, Article number, 83-1023-01
Creator: Phadia US Inc
Published: 2017-01-30
License: https://open.fda.gov/license/

Phadia AB / initiated 2017-01-30 / Terminated

FDA source

Phadia US Inc began a recall of EliA Sample Diluent, Article number, 83-1023-01 on 2017-01-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1253-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-30
Posted: 2017-02-24
Terminated: 2017-08-07
Recalling firm: Phadia AB
Product: EliA Sample Diluent, Article number, 83-1023-01
Product code: NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
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.
FDA root cause: Under Investigation by firm
Action: Phadia AB, part of Thermo Fisher Scientific, is voluntarily recalling EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C, written notices were mailed via FedEx on 01/30/2017. There have been reports of instrument malfunctions for Phadia 250 due to deformed bottles for the below mentioned product and lots. The deformation of the bottle can cause an erroneous volume detection by the instrument which will result in insufficient aspiration of sample diluent, thus generating insufficient dilution of patient samples. The deformation is described as a flange or brim, located on the inside lower part of the vial opening. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: Stop using the affected lots of the above mentioned product lots Please, return or attest to scrapping of any unused product lots to the manufacturer and order replacement products free of charge. Review your records to determine if you have had instrument problems due to deformed bottles. If you find the instrument error message 3-145 RIGHT ARM LIQUID DETECTION BELOW LOWER LIMIT Target 2, please collect all log files available and/or contact customer support, who will further assist in assessing possible impact on the test results in scope. Fill in the Medical Device Recall return response on page 3 and return to the manufacturer by e-mail. If customers have any questions, please contact Phadia US, Inc. at 1-800-346- 4364, option #2.
Quantity in commerce: 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
Product codes and lots: EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1253-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1253-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-08	2017-02-24

Product code NHX

K061165Class IIElia Ccp, Model 14-5515-01; Elia Ccp Control, Model 83-1009-01Sweden Diagnostics (Us), Inc. / cleared 2006-08-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)