CLASS II ONGOING Device recall · Reported 16 Apr 2025 · FDA Enforcement Report
Atellica CH Revised C Reactive Protein (RCRP) recalled
Siemens Healthcare Diagnostics is recalling Atellica CH Revised C Reactive Protein (RCRP), distributed nationwide in the US. The recall was initiated on 11 Mar 2025 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-1551-2025
- FDA event ID
- 96440
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Mar 2025
- FDA classified
- 10 Apr 2025
- Reported
- 16 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 11 Mar 2025 | Recall initiated by company | |
| 10 Apr 2025 | Classified by FDA | +30 days |
| 16 Apr 2025 | 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
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Where it was distributed
Domestic: Nationwide Distribution. International: Australia, Austria, Bahamas, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark,¿Estonia, Finland, France, Germany, Greece,¿Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Malaysia, Maldives, Netherlands, New Zealand, Norway, Oman,¿Pakistan, Poland, Portugal, Qatar, Romania, Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South¿Africa, Spain, Sweden, Switzerland, Taiwan, U.A.E., Uganda, United¿Kingdom, Uzbekistan, Vatikancity.¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿¿
Questions about this recall
Why was it recalled?
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
Which lots are affected?
Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots.
Where was it sold?
Domestic: Nationwide Distribution. International: Australia, Austria, Bahamas, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark,¿Estonia, Finland, France, Germany, Greece,¿Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Malaysia, Maldives, Netherlands, New Zealand, Norway, Oman,¿Pakistan, Poland, Portugal, Qatar, Romania, Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South¿Africa, Spain, Sweden, Switzerland, Taiwan, U.A.E., Uganda, United¿Kingdom, Uzbekistan, Vatikancity.¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿¿
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.
More recalls from Siemens Healthcare Diagnostics
All 695| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Atellica CH Revised C-Reactive Protein (RCRP) recalled | Siemens Healthcare Diagnostics | Other | Nationwide |
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