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Atellica CH Calcium_2 (CA_2), Siemens Material Number… recallZ-0928-2022 · Siemens Healthcare Diagnostics, Inc. · initiated Feb 9, 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

Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

FDA root cause category: Device Design

What the company is doing

Urgent Medical Device Correction notification letters dated 2/9/22 were sent to customers. Actions to be Taken by the Customer Please review this letter with your Medical Director. Perform the instructions provided in the Additional Information section below. 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 representative. Please retain this letter with your laboratory records and forward this letter to those who may have received these products. Additional Information If your laboratory has multiple Atellica CH 930 Analyzers, separate the assays as follows: -LITH_2 from CA_2 and TBil_2 -A1c_E/A1c_H from CA_2 - CA_2 from UN_c (urine only); UN_c serum and plasma are not impacted and can be run on the same analyzer as CA_2 -Fruc from AAT, IgA_2, IgM_2 and Theo If you choose not to separate the assays as indicated above, batch testing of A1c_E, Fruc, LITH_2, and UN_c (urine only) may be considered. Note: An RPC2 wash mitigation must be initiated after completion of A1c_E, Fruc, LITH_2, and prior to UN_c (urine only). 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. If you have any questions, contact your local Siemens Healthineers technical support representative.

Recall details

Recall number
Z-0928-2022
Status
Open, Classified
Initiated by the company
Feb 9, 2022
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
2,395
Product code
CJY
FDA submissions
K083386
Distribution
Global Distribution. US Nationwide.

Product description

Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644

Code information (models, lots, serial numbers)

UDI: 00630414220697; Lot Numbers: 211392 211438 211484 211522 211526

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

3 devices cleared under K083386 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 89740).

Sources and updates

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