Z-0100-2024Class II

Access Thyroglobulin Calibrators

Name: Z-0100-2024 Access Thyroglobulin Calibrators
Creator: Beckman Coulter, Inc.
Published: 2023-07-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-07-06 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of Access Thyroglobulin Calibrators on 2023-07-06. FDA classified it as Class II and gives the reason as "It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11%...". 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-0100-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-06
Posted: 2023-10-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Thyroglobulin Calibrators
Product code: MSW System, Test, Thyroglobulin
Reason for recall: It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Beckman Coulter issued an Urgent Medical Device Recall letter dated 06/28/2023 to its consignees affected worldwide on 07/06/2023 via email or letter and followed with an updated letter (dated 07/07/2023) issued on 07/14/2023 which contained FDA suggested edits. The notice explained the problem, the risk to the patient and requested the following actions be taken: If you have downloaded the alternative calibrator card issued in April 2023, please discard that calibrator card, and do not use it moving forward. . Only use Access Thyroglobulin calibrator lots 338013 or higher to calibrate Access Thyg reagent packs (C71762), when this becomes available in your laboratory. . Continue to use any lot of Thyroglobulin Calibrator (PN 33865) with Access Thyroglobulin Reagent packs (33860). The firm issued an Important Product Notification letter was issued on 2023 August 10 notifying customers in the US, Canada, and China that they were NOT affect by this issue and to disregard the prior Urgent Medical Device Recall letters.
Quantity in commerce: 5980 units
Distribution: worldwide except US, Canada, and China
Product codes and lots: UDI/DI 15099590227166, Serial/Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, 337940

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0100-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0100-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-11

Product code MSW

K031269Class IIAccess Thyroglobulin Reagents on the Access Immunoassay SystemsBeckman Coulter, Inc. / cleared 2003-05-02

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)