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Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use… recallZ-1498-2022 · Siemens Healthcare Diagnostics, Inc. · initiated Jun 28, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-1498-2022
Status
Open, Classified
Initiated by the company
Jun 28, 2022
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
1614 units US ; 7,979 units OUS
Product code
JIY
FDA submissions
K991576
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 description

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.

Code information (models, lots, serial numbers)

Unique Device Identification (UDI): 00630414596402 All lots

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

6 devices cleared under K991576 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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