Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive Protein
Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Revised C-Reactive Protein – 42940 units (3938 US, 39002 OUS). The U.S. Food and Drug Administration published the recall on October 7, 2026; it began on August 17, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Share
| Product | Atellica CH Revised C-Reactive Protein |
| Brand | Siemens Healthcare Diagnostics |
| Company | Siemens Healthcare Diagnostics, Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 17, 2026 |
| Published by FDA | October 7, 2026 |
| Quantity | 42940 units (3938 US, 39002 OUS) |
| Recall ID | 99726 |
Recalled products
- Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
- FDA recall number
- Z-3335-2026
- Codes, lots and dates
- Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots;
- Quantity
- 42940 units (3938 US, 39002 OUS)
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99726
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Tarrytown, NY, United States
Why it was recalled
The reason the FDA lists: “The potential for falsely elevated results.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., Uganda, United Kingdom , Uruguay, Uzbekistan, Vatikancity, Vietnam, Zaire.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99726, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Siemens Healthcare Diagnostics recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Aug 26, 2026 |  Siemens Healthcare Diagnostics recall: Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL and 1 more productMedical devices · 20 units; 55 units | Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quini… Serious | FDA Class II |
Other medical device recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 | Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 units | Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious | FDA Class I |
| Oct 7, 2026 | Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 total | a fire hazard Most serious | FDA Class I |
| Oct 7, 2026 | Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepieces | Due to incorrect inside packaging label for eyepiece. Serious | FDA Class II |
| Oct 7, 2026 | Noxbox recall: NOxBOXi Nitric Oxide Delivery SystemMedical devices · 1,667 units | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxy… Serious | FDA Class II |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
| Oct 7, 2026 | Beckman Coulter Mishima K.K recall: Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480…Medical devices · 492 units | Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may outpu… Serious | FDA Class II |
About this recall
Is Siemens Healthcare Diagnostics Atellica CH Revised C-Reactive Protein recalled?
Yes. Siemens Healthcare Diagnostics, Inc. recalled it on August 17, 2026; FDA published it October 7, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
The potential for falsely elevated results.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.