Agency classClass IIOur severity:High FDA (Devices)·Z-0928-2022·Announced 2022-04-20

Siemens Atellica CH Calcium_2 Reagent Carryover Recall

Siemens is recalling Atellica CH Calcium_2 diagnostic reagent due to potential reagent carryover that could impact quality control, patient samples, and calibrator results. The recall affects approximately 2,395 units distributed globally and in the US.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II diagnostic reagent recall where a potential quality control issue—reagent carryover—could impact patient test results. No illnesses or injuries have been reported, qualifying this as a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Calcium_2 (CA_2) reagent, Siemens Material Number 11097644, due to a potential for reagent carryover that could impact quality control results, patient test results, and calibrator accuracy.

Approximately 2,395 units of this diagnostic reagent are affected. The recall involves lot numbers 211392, 211438, 211484, 211522, and 211526 (UDI: 00630414220697). The affected product has been distributed globally and throughout the United States.

Laboratories using affected lots should assess their quality control data and patient results from samples tested with this reagent. Healthcare facilities should contact Siemens Healthcare Diagnostics, Inc. for instructions on handling affected inventory and verifying the accuracy of previous test results.

The recalled product

Product: Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — Diagnostic Reagent
Hazard: reagent-carryover
inaccurate-results
Affected units: 2,395

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

UDI: 00630414220697
Lot Numbers: 211392 211438 211484 211522 211526

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · reagent carryover