Z-1009-2026Class II

The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated...

Name: Z-1009-2026 The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated...
Creator: Roche Diagnostics Operations, Inc.
Published: 2025-11-21
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2025-11-21 / Open, Classified / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection... on 2025-11-21. FDA classified it as Class II and gives the reason as "Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1009-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-21
Posted: 2026-01-02
Recalling firm: Roche Diagnostics GmbH
Product: The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.
Product code: JZO System, Test, Thyroid Autoantibody
Reason for recall: Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Firm notified customers on November 21, 2025 via Urgent Medical Device Correction notices. Customers using the cobas e 402/801 and cobas e411 were instructed to immediately discontinue using the impacted lots outlined in the UMDC and switch to the new unaffected lot numbers listed in the communication.
Quantity in commerce: 1300 cassettes
Distribution: US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, ME, MI, MN, NC, NJ, NM, NY, OH, PA, PR, TN, TX, UT, WA, WV.
Product codes and lots: 08496633190 lot 840183 exp. 02/26 08496633190 lot 874011 exp. 10/26 08496609190 lot 840177 exp. 05/26

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1009-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1009-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-14	2026-01-02

Product code JZO

K193313Class IIElecsys Anti-TSHRRoche Diagnostics / cleared 2020-02-27

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)