iChem VELOCITY Urine Chemistry Analyzer
Medical device recall Z-0843-2020. Published in FDA’s Enforcement Report on Jan 29, 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 Jan 29, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 4314 units 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?
Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
iChem VELOCITY Urine Chemistry Analyzer
4314 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All serial numbers and SW versions V01257 V02416 V01444 V02619 V02959 V03933 V03934 V02022 V02027 V04322 CV04002 V03288 CV04113 V04236 V03472 V04250 V02367 V02287 V01134 V03796 V02453 V03186 V02317 V04256 V03114 V01360 V01655 V02065 V04528…
Every code shown here, 1,998 characters
All serial numbers and SW versions V01257 V02416 V01444 V02619 V02959 V03933 V03934 V02022 V02027 V04322 CV04002 V03288 CV04113 V04236 V03472 V04250 V02367 V02287 V01134 V03796 V02453 V03186 V02317 V04256 V03114 V01360 V01655 V02065 V04528 CV04005 V02330 V02323 V02329 V02326 V04511 V02642 V03571 V03428 V02909 V01251 V01115 V02081 V02248 V03575 CV04036 V03403 V04388 V04387 V04389 V04328 V04390 V04141 CV04076 V01214 V04227 V02438 V02449 V02485 V02423 V02432 V02614 v01838 V02649 V02502 V02652 V02464 V02634 V02635 V02450 V02534 V02436 V02536 V02459 V04312 V02530 V02463 V02535 V02435 V04284 CV04083 CV04047 CV04084 V03409 V03413 V01689 V01753 V01754 V03854 V03722 V04753 V02243 V02242 V03851 V03925 V04369 V02026 CV04165 V03848 V04540 V04516 V04515 V01404 V02430 V03565 V04706 V01335 V02234 V02373 V02892 V01829 V02446 V01188 V02782 V03456 V01429 V02021 V02020 V02966 V02949 V04767 V04674 V04770 CV04003 V04769 V04740 CV04004 V02899 V01977 V04538 V04309 V04607 V01318 V01546 V04257 V03566 V01548 V01547 V02753 V01541 V01542 V03922 V02369 V01555 V02070 V02181 V01720 CV04086 V03834 V04291 V04549 V02913 V04590 V03798 V01911 V01998 V03567 V04258 CV04125 V03238 V04329 V03327 V04592 V03271 V01776 V01712 V04702 CV04163 V04519 V02086 V01824 V01467 V03100 V04669 V04464 V04471 V04584 CV04229 CV04228 CV04196 CV04227 CV04265 V04654 V01872 V04138 CV04132 V04732 V02210 V03003 V03283 V03285 V04432 CV04144 V01182 V01179 V03033 V02361 V04433 V01842 V04377 V01717 V03776 V01831 V03890 V01567 V01568 V03237 V03000 V02998 CV04067 V04775 V03464 V02046 V01581 V01493 V03842 CV04209 V04379 V01460 V03113 CV04043 V01146 V01781 V04545 V04547 V04606 V04302 V04434 V04689 V04195 V04559 V03251 V04153 V02650 V02121 CV04085 CV04082 V02752 V02645 CV04121 V02641 V02640 CV04116 V03152 V01264 V03462 CV04109 V04675 V02084 V01109 V01950 V01944 V01443 V01207 V01209 V02132 V03465 V02439 V03417 V03797 CV04060 V02185 V01432 V02150 V02078 V02194 V02127 V02217 V02810 V04655 V03748 CV04140 V01533 V02957 V01864 V04318 V04385…
FDA’s list runs to 33,197 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.
Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, France, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Macau, Malaysia, Maldives, Mexico, Moldova, Montenegro, Morocco, Netherlands, Netherlands Antillean, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam.
The states and territories these words name
- Puerto Rico
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.
The words say it went outside the United States too.
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 Nov 7, 2019.
- FDA classified it on Jan 23, 2020.
- FDA’s Enforcement Report published it on Jan 29, 2020.
- FDA terminated it on Sep 11, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Beckman Coulter Inc., of Brea, CA.
- 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 33,197 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
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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.