Z-1498-2022Class II

Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human...

Name: Z-1498-2022 Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2022-06-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-06-28 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples on 2022-06-28. FDA classified it as Class II and gives the reason as "Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1498-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-28
Posted: 2022-08-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
Product code: JIY Photometric Method, Iron (Non-Heme)
Reason for recall: Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.
FDA root cause: Under Investigation by firm
Action: Siemens issued Urgent Medical Device Correction (UMDC) Letter by FedEx beginning on 06/28/2022. Letter states reason for recall, health risk and action to take: For customers operating with Atellica Software v.1.25.2 and lower, the resolution of this issue will be implemented in Atellica Software v1.25.3 which will be available soon. In the interim, please follow the instructions in the Additional Information section. Customers who are operating with Atellica Software v1.26 will receive further information when a software update to resolve the issue is available. For laboratories operating with Atellica Software v1.25.2 and below and Atellica Software v1.26 follow the workaround instructions in the Additional Information section until a future version of software is available. If your laboratory has multiple Atellica CH 930 Analyzers, Siemens recommends testing the Atellica CH ALB_2 assay on a separate analyzer from the Iron_2 assay. " If you choose not to separate the assays as indicated above, batch testing of Atellica CH ALB_2 may be considered. " If Iron_2 and ALB_2 will be processed on the same Atellica CH analyzer, an RPC2 wash mitigation must be initiated after processing Iron_2 and prior to processing ALB_2. Note: Any of the following will initiate the RPC2 wash: " After the Atellica CH 930 Analyzer has been in standby for 12 minutes. " After completion of any Open Channel assay. " Restarting the Atellica CH 930 Analyzer. Refer to the Atellica Solution Online Help for instructions on system restart Please review this letter with your Medical Director. Perform the instructions provided in Additional Information. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support
Quantity in commerce: 1614 units US ; 7,979 units OUS
Distribution: Worldwide distribution - US Nationwide and the countries of AR, AU, AT, BS, BH, BD, BE, BR, BG, BF, CA, CL, CO, HR, CW, CZ, DK, EC, EG, EE, FI, FR, DE, GR, GP, HK, HU, IN, IR, IQ, IE, IL, IT, JP, JO, KE, KW, LV, LY, LT, MY, MX, MA, NL, NZ, NO, OM, CN, PK, PY, PE, PH, PL, PT, QA, KR, RO, RU, SA, RS, SG, SK, ZA, ES, SE, CH, TW, TH, TR, AE, UG, GB, UY, VA, VN.
Product codes and lots: Unique Device Identification (UDI): 00630414596402 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1498-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1498-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-10	2022-08-04

Product code JIY

K991576Class IIAdditional Assays for the Bayer Advia 1650 Chemistry SystemBayer Corp. / cleared 1999-06-30

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)