Z-0889-2026Class II

Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and...

Name: Z-0889-2026 Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and...
Creator: Beckman Coulter, Inc.
Published: 2025-11-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-11-07 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay... on 2025-11-07. FDA classified it as Class II and gives the reason as "It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could...". 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-0889-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-07
Posted: 2025-12-09
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 10/29/25 was sent to customers. Check your inventory of Access 2 RVs for the lots listed at the top of this letter. "If you have the lots listed above contact Beckman coulter for replacement RVs. "You may continue to use the lots listed above until you have received a sufficient supply of replacement RVs. Once replacement RVs arrive, then dispose of the lots listed above according to your local regulations. "If you do not have the RV lots listed above, then no further action is needed. Retrospective review of results is not necessary because this issue does not affect individual patient results. Please contact your local Beckman Coulter representative for replacement product requests. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: "Electronically, if you received this communication via email. "Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support Center: "From our website: http://www.beckmancoulter.com "Contact your local Beckman Coulter Representative for replacement.
Quantity in commerce: 38,225 untis
Distribution: US Nationwide. Global Distribution.
Product codes and lots: UDI-DI: 15099590180249; Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0889-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0889-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-09

Product code JJE

K121214Class IIAccess Accutni+3 Reagent and Access Accutn1+3 Calibrators for Use on the Access 2 Immunoassay SystemBeckman Coulter, Inc. / cleared 2013-06-14

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)