Siemens Healthcare Diagnostics, Inc.: 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.

Recall number

Z-1498-2022

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.

Status

Open, Classified

Initiated

2022-06-28

Posted

not on file

Terminated

not on file

Reason

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.

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

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.

Lot, serial or model codes

Unique Device Identification (UDI): 00630414596402 All lots

510(k) numbers

["K991576"]

PMA numbers

not on file

Product code

JIY

Firm FEI

2432235

Firm city

Tarrytown

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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