CLASS II ONGOING Device recall · Reported 6 Sep 2023 · FDA Enforcement Report
Atellica CH Triglycerides (concentrated)-In vitro recalled
Siemens Healthcare Diagnostics is recalling Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative, distributed nationwide in the US. The recall was initiated on 27 Jan 2023 and the FDA has classified it as Class II.
Check your package
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-1270-2023
- FDA event ID
- 91665
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jan 2023
- FDA classified
- 29 Aug 2023
- Reported
- 6 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 27 Jan 2023 | Recall initiated by company | |
| 29 Aug 2023 | Classified by FDA | +214 days |
| 6 Sep 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Product as listed by the FDA
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica CH Analyzer SMN: 11097591
Where it was distributed
Nationwide Foreign: Country Albania Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile China Colombia Croatia Cura¿ao Czech Republic Denmark Ecuador Egypt Finland France Germany Greece Guadeloupe Hong Kong Hungary India Ireland Israel Italy Japan Kuwait Libya Malaysia Mexico Netherlands New Zealand Norway Oman Pakistan Paraguay Peru Philippines Poland Portugal Qatar Republic Korea Romania Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan, Province of China Thailand Ukraine United Arab Emirates United Kingdom Great Britain Uruguay Vatikancity Vietnam
Questions about this recall
Is Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative recalled?
Yes. Siemens Healthcare Diagnostics recalled Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative on 27 Jan 2023. The recall is Class II and its status is Ongoing. Recall number Z-1270-2023.
Why was it recalled?
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Which lots are affected?
UDI: 00630414596495 All Lots
Where was it sold?
Nationwide Foreign: Country Albania Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile China Colombia Croatia Cura¿ao Czech Republic Denmark Ecuador Egypt Finland France Germany Greece Guadeloupe Hong Kong Hungary India Ireland Israel Italy Japan Kuwait Libya Malaysia Mexico Netherlands New Zealand Norway Oman Pakistan Paraguay Peru Philippines Poland Portugal Qatar Republic Korea Romania Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan, Province of China Thailand Ukraine United Arab Emirates United Kingdom Great Britain Uruguay Vatikancity Vietnam
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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