Z-1112-2025Class II

Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems

Name: Z-1112-2025 Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Creator: Beckman Coulter Inc.
Published: 2025-01-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-01-02 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems on 2025-01-02. FDA classified it as Class II and gives the reason as "Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time...". 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-1112-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-02
Posted: 2025-02-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Product code: PTF Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Reason for recall: Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall letter was sent during the week of December 30, 2024, to the affected customers via first class mail and email. If a passing calibration curve can be generated using the Access PCT reagent lots listed above, no action is needed. If repeated calibration failures with a failure code of Max Iterate are obtained using the Access PCT reagent lots listed above, discontinue using the affected reagent lot number.
Quantity in commerce: 6,994 US; 10,067 OUS
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Kazakhstan, Korea, Republic of, Malaysia, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Slovakia, South Africa, Spain, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam.
Product codes and lots: UDI-DI 15099590736002 Lots 339062, 439811

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1112-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1112-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-05

Product code PTF

K192271Class IIAccess PCT, Access PCT CalibratorsBeckman Coulter, Inc. / cleared 2019-11-26

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)