Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Medical device recall Z-1797-2020. Published in FDA’s Enforcement Report on May 6, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 6, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1807 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
1807, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 00630414002163; All systems with software version v1.21.0 SP1 or lower Serial Numbers: CM01702 CM01708 CM00184 CM00196 CM01051 CM01467 CM00770 CM00815 CM00983 CM01053 CM00802 CM01004 CM01903 CM00526 CM00635 CM00809 CM00733 CM00735…
Every code shown here, 1,996 characters
UDI: 00630414002163; All systems with software version v1.21.0 SP1 or lower Serial Numbers: CM01702 CM01708 CM00184 CM00196 CM01051 CM01467 CM00770 CM00815 CM00983 CM01053 CM00802 CM01004 CM01903 CM00526 CM00635 CM00809 CM00733 CM00735 CM01045 CM01050 CM01052 CM01059 CM00420 CM00632 CM00633 CM00209 CM00210 CM01799 CM01590 CM01612 CM01047 CM01048 CM00859 CM00865 CM01624 CM01626 CM00829 CM00830 CM00651 CM00654 CM01603 CM01608 CM01695 CM01701 CM00749 CM00786 CM01567 CM01569 CM01682 CM01683 CM00773 CM01431 CM01474 CM01583 CM01598 CM01602 CM00148 CM00151 CM00152 CM01907 CM01738 CM01739 CM01105 CM00799 CM00800 CM01823 CM01917 CM01409 CM01410 CM01588 CM01600 CM01274 CM01306 CM00947 CM00948 CM01660 CM01661 CM00812 CM00828 CM00820 CM01593 CM01594 CM01585 CM01599 CM01058 CM00421 CM00606 CM00331 CM00333 CM01133 CM01149 CM01619 CM01191 CM01200 CM00769 CM00858 CM01237 CM01259 CM00797 CM00798 CM01589 CM01614 CM00426 CM00427 CM00701 CM00704 CM01264 CM01278 CM01391 CM01512 CM00611 CM00612 CM01735 CM00643 CM00646 CM00831 CM00832 CM01761 CM01772 CM01727 CM01740 CM01745 CM00315 CM00316 CM00123 CM00181 CM01031 P-P1-07 CM00147 CM00432 CM00297 CM00430 CM00780 CM01296 CM00268 CM00271 CM00265 CM00267 CM01759 CM01760 CM01579 CM01611 CM01139 CM00607 CM00625 CM01699 CM01716 CM00884 CM00888 CM00577 CM00631 CM01650 CM00459 CM00510 CM01441 CM01343 CM01394 CM00973 CM00977 CM01586 CM01616 CM01620 CM01621 CM00634 CM00637 CM01400 CM01406 CM00626 CM00627 CM01344 CM01345 CM00418 CM00419 CM00724 CM00628 CM00630 CM00958 CM00979 CM00971 CM00481 CM00482 CM01066 CM01118 CM01923 CM01675 CM01241 CM01253 CM01242 CM01255 CM01247 CM01268 CM01801 CM01528 CM01529 CM00864 CM00867 CM00400 CM00407 CM01455 CM01459 CM00851 CM00852 CM01499 CM00330 CM00343 CM00344 CM01513 CM01553 CM01818 CM01819 CM01597 CM00905 CM00915 CM00917 CM00918 CM00457 CM00458 CM01065 CM01239 CM01245 CM00639 CM00640 CM00746 CM00747 CM00748 CM01694 CM01696 CM00182 CM00183 CM01401 CM01423 CM00422 CM00423 CM00424 CM00425 CM00781 CM01576 CM00833…
FDA’s list runs to 11,284 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide. Global distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 27, 2020.
- FDA classified it on Apr 24, 2020.
- FDA’s Enforcement Report published it on May 6, 2020.
- FDA terminated it on Oct 25, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Healthcare Diagnostics, Inc., of Tarrytown, NY.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 11,284 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.