Z-2472-2023Class II

Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in...

Name: Z-2472-2023 Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2023-07-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-07-10 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA... on 2023-07-10. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2472-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-10
Posted: 2023-08-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214
Product code: JFM Enzymatic Method, Bilirubin
Reason for recall: 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), Atellica CH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 6733 units
Distribution: US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam
Product codes and lots: Unique Device Identification (UDI): 00630414611037 All Lot Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2472-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2471-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-28
Z-2472-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-28
Z-2473-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-28
Z-2474-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-28

Product code JFM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)