Lower riskMedical device recall · FDA · Published July 6, 2021
Siemens Atellica IM BR 27.29 Kit: Calibration Interval Error
Siemens Healthcare recalls Atellica IM BR 27.29 Assay 250 Test Kits due to incorrect calibration interval in instructions. Kits may give inaccurate cancer antigen CA 27.29 results if used beyond 3-day calibration.
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
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Contact the company
📍Recalling firmSiemens Healthcare Diagnostics, Inc333 Coney St · East Walpole, MA 02032-1516
✎ GovInfoNow plain-language explainer
Siemens Healthcare is recalling Atellica IM BR 27.29 Assay 250 Test Kits because the calibration interval in the instructions was incorrectly set to 10 days instead of 3 days. This could lead to inaccurate cancer antigen CA 27.29 test results if the kit is used beyond the proper calibration period. Read more at govinfonow.com/recall/62238-siemens-atellica-im-br-27-29-kit-calibration-interval-error.
“Siemens Atellica IM BR 27.29 Kit: Calibration Interval Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62238-siemens-atellica-im-br-27-29-kit-calibration-interval-error. Based on FDA recall #Z-2425-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2425-2021%22&limit=1).
The FDA announced on July 6, 2021, that Siemens Healthcare Diagnostics, Inc. is recalling Atellica IM BR 27.29 (BR) Assay 250 Test Kits because they do not meet the claimed Pack Calibration Interval of 10 days. The agency issued recall number Z-2425-2021 for the Class II voluntary recall.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica IM BR 27.29 (BR) Assay 250 Test Kit
Distribution: Worldwide, including US, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
The hazard
According to the FDA, the product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. The IFU calibration was updated to change the interval from 10 days to 3 days for all current and future kit lot numbers.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Recent brand recalls include the Siemens Atellica CH RCRP Test recall on Aug. 17, 2026, for potential false high results, and the Siemens Healthcare Syva EMIT 2000 Quinidine Assay recall on July 13, 2026, due to unacceptable precision performance. Other recent recalls of similar products include the Roche Elecsys Anti-TSHR Assay recall (Nov. 21, 2025), the Aniara Diagnostica ZYMUTEST HIA IgG Kit recall (April 1, 2026), and the Medline Convenience Kits recall (Jan. 7, 2026).
How to tell if you have this one
Check for lot numbers 48553255, 78009255, or 90311257 with expiration dates 2021-08-03 or 2021-11-10. The kit is used for cancer antigen CA 27.29 testing in human serum and plasma.
Brand
Siemens Healthcare
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
Recall number
Product, codes & lots
Quantity
Z-2424-2021
Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478; All lots impacted. Kit lot numbers: 40476255 & 64505255 expiration date 2021-08-03, Lot numbers: 89332257 & 05694257 expiration date 2021-11-10.
580 units
Z-2425-2021
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477; All lots impacted Kit lot numbers: 48553255 & 78009255 expiration date 2021-08-03, Lot number: 90311257 expiration date 2021-11-10.
437 units
Z-2426-2021
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236; All lots impacted Kit lot numbers: 41331255 & 74682255 expiration date 2021-08-03, Lot number: 91605257 expiration date 2021-11-10.
787 units
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for lot numbers 48553255, 78009255, or 90311257 on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2425-2021 (July 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2425-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.