Z-1907-2019Class II

EliA RF IgM Well, REF 14-5600-01

Name: Z-1907-2019 EliA RF IgM Well, REF 14-5600-01
Creator: Phadia Ab
Published: 2019-05-10
License: https://open.fda.gov/license/

Phadia AB / initiated 2019-05-10 / Terminated / root cause: manufacturing process

FDA source

Phadia Ab began a recall of EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor... on 2019-05-10. FDA classified it as Class II and gives the reason as "Potential for reporting low assay results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1907-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-10
Posted: 2019-07-01
Terminated: 2020-06-02
Recalling firm: Phadia AB
Product: EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000.
Product code: DHR System, Test, Rheumatoid Factor
Reason for recall: Potential for reporting low assay results
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On May 10, 2019, Corporate Thermo Fisher Scientific issued URGENT FIELD SAFETY NOTICES to customers by FedEx. Actions To Be Taken: Please review patient results obtained from lot 0085 and make note of the following: 1. If you have any of the above referenced material on hand, please discontinue use immediately and discard per your internal procedures. Notify all affected users in your facility to do the same. 2. All samples reported as positive (> 5 IU/ml) are positive, however the true concentration could be higher than reported. 3. The true concentration of a reported sample equal to 3.5 5 IU/ml could potentially be a positive sample. 4. Negative results between 2 IU/ml and 3.5 IU/ml are potentially false negative results. 5. Negative results < 2 IU/ml could be higher, but would still be reported as a negative result with a 60% higher concentration. 6. Complete and return the Customer Response Form. If you have any questions concerning this issue, please contact Phadia US, Inc. Technical Support at 1-800-346-4364, option #2.
Quantity in commerce: 30 kits
Distribution: US Nationwide n the states of NJ, NY, MI, WV, TX including PR
Product codes and lots: UDI (01) 07333066010854 (17) 200630 (10) 0085 Lot Number - 0085

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1907-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1907-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-01

Product code DHR

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)