CLASS II ONGOING Device recall · Reported 20 Apr 2022 · FDA Enforcement Report

Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H) recalled

Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536, distributed nationwide in the US. The recall was initiated on 9 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 00630414220505; Lot Numbers: 110027 110060 110065 110091 110113 110129 110137 110161 110170 110208 110224 110234 110235 110262 110265 110273 110286 110315 110330 110347 110360

Quantity recalled6606

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0929-2022
FDA event ID: 89740
Recalling firm: Siemens Healthcare Diagnostics, Tarrytown, NY
Classification: Class II
Status: Ongoing
Recall initiated: 9 Feb 2022
FDA classified: 14 Apr 2022
Reported: 20 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

9 Feb 2022	Recall initiated by company
14 Apr 2022	Classified by FDA	+64 days
20 Apr 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536

Where it was distributed

Global Distribution. US Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

UDI: 00630414220505; Lot Numbers: 110027 110060 110065 110091 110113 110129 110137 110161 110170 110208 110224 110234 110235 110262 110265 110273 110286 110315 110330 110347 110360

Where was it sold?

Global Distribution. US Nationwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 89740

This product is part of a recall event; the main page for the event is Atellica CH Fructosamine (Fruc), Siemens Material Number recalled.

Reported	Class	Recall	Company	Reason	Where
20 Apr 2022	CLASS II	Atellica CH Fructosamine (Fruc), Siemens Material Number recalled	Siemens Healthcare Diagnostics	Other	Nationwide
20 Apr 2022	CLASS II	Atellica CH Lithium_2 (LITH_2), Siemens Material Number recalled	Siemens Healthcare Diagnostics	Other	Nationwide
20 Apr 2022	CLASS II	Atellica CH Calcium_2 (CA_2), Siemens Material Number recalled	Siemens Healthcare Diagnostics	Other	Nationwide

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