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Atellica CH Total Bilirubin_2 -In vitro diagnostic use in… recallZ-2471-2023 · Siemens Healthcare Diagnostics, Inc. · initiated Jul 10, 2023

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

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica CH Total Bilirubin_2 (TBil_2), AtellicaCH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and AtellicaCH HDL Cholesterol (HDLC)

FDA root cause category: Under Investigation by firm

What the company is doing

Siemens Healthineers issued Urgent Medical Device Correction ACHC23-01.C.US to US affected customers via FedEx beginning on 07/10/2023; and Urgent Field Safety Notice ACHC23-01.C.OUS,OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 07/10/2023. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Perform the instructions provided in the Additional Information section. 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 this product. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. If your laboratory has multiple Atellica CH 930 Analyzers, separate the assays as follows: " Perform testing of TBil_2 on a separate analyzer from Glucose Oxidase (GluO) " Perform testing of LDLC on a separate analyzer from Lipase (Lip) " Perform testing of GGT on a separate analyzer from Magnesium (Mg) " Perform testing of HDLC on a separate analyzer from Uric Acid (UA) If you choose not to or are unable to separate the assays as indicated above, batch testing of GluO, Lip, Mg and UA may be performed. Note: When batch testing impacted assays, GluO, Lip, Mg and UA, an RPC2 wash mitigation must be initiated after completion of tests with the assay causing carryover, TBil_2, LDLC, GGT and HDLC, respectivel

Recall details

Recall number
Z-2471-2023
Status
Open, Classified
Initiated by the company
Jul 10, 2023
Posted by the FDA
Aug 28, 2023
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
50148 units
Product code
JFM
FDA submissions
K170065
Distribution
US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam

Product description

Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531

Code information (models, lots, serial numbers)

Unique Device Identification (UDI): 00630414595818 All Lot Numbers

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

2 devices cleared under K170065 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 92800).

Sources and updates

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