—#194780

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.

FDA product code: JIY — Photometric Method, Iron (Non-Heme)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K991576
Affected lot / code info: Unique Device Identification (UDI): 00630414596402 All lots

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2022-06-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194780. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.