iChemVELOCITY Urine Chemistry System
Medical device recall Z-1384-2017. Published in FDA’s Enforcement Report on Mar 8, 2017.
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 Mar 8, 2017. 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
- 3175 units total (1697 units in US) 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?
The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips
3175 units total (1697 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number V01257 V02416 V02619 V01444 V02906 V02959 V03934, V03933 V02027, V02022, V04322 V03288 V03314 V02330 V02326 V02329 V02642 V02323 V03571 V03428 V02909, V01251 V01115 V02081 V02248 V03575 V03854 V03403 V04387 V04388, V01406…
Every code shown here, 1,998 characters
Serial Number V01257 V02416 V02619 V01444 V02906 V02959 V03934, V03933 V02027, V02022, V04322 V03288 V03314 V02330 V02326 V02329 V02642 V02323 V03571 V03428 V02909, V01251 V01115 V02081 V02248 V03575 V03854 V03403 V04387 V04388, V01406 V01556 V04328 V04390, V01557 V04141 V02103 V01214 V04227, V02438 v01838 V04284 V02535 V02534 V02449 V04312 V02538 V02635 V02530 V02450 V02634 V02485 V02436 V02614 V02463 V02652 V02502 V02536 V02464 V02423 V02435 V02432 V02649 V02459 V02537 V03883 V01689 V03409, V03413 V01753, V01754 V02243 V02985 V02242 V03976 V03851 V03925 V04369 V02026 V03848 V01404 V02430 V03565 V02234 V02373 V01829 V02446 V02703 V01429 V02949 V02899 V04309 V01318 V01546 V04257 V03566 V01548 V01547, V02753 V01541 V01542 V02369, V03922 V01555 V02181 V02070 V01762 V04357 V04350 V04349 V04356 V04291 V01720 V03834 V02335 V03798 V01911 V01998 V03567 V04258 V03238 V04329 V03327 V01776 V01712 V03271 V01966 V01824, V02086 V01467 V03100 V01872 V04138 V02047 V02210 V03221 V03003 V03285, V03283 V02025 V01179 V01182 V03033 V02361 V01842 V02931 V01717, V04377 V03776 V01831 V03890 V01335 V01567,V01568 V03237 V03000 V02998 V03464 V02046 V01581 V01493 V03842 V04379 V01460 V04348 V03113 V01146 V01781 V04302 V01558 V04195 V03251 V04153 V02650 V03417 V02935 V02185 V01432 V02150 V03456 V02782 V02194 V02078 V02127 V02217 V02810 V03748 V01533 V02957 V01864 V04385, V01632, V01633 V04318 V03008 V03011, V03047 V02492 V01135 V01161 V02602 V02934 V01482 V02186 V02884 V02411 V01200 V03245 V01627 V01877 V01094 V01092 V01303 V01332 V02962 V03090 V04341 V03977, V03953 V01876 V01147 V03797 V02809 V03467 V03700 V03775 V04335, V03357 V02180 V01376 V01978, V01981 V01985 V03438 V01486 V02460 V01642 V01616 V03427 V01502 V03889 V03105, V03106, V03107 V02269 V01713 V03384 V03716 V02808 V01620 V03858 V01649 V02295, V02306 V02468 V01059 V04372 V01645 V03441, V03376 V02874 V03145 V01375 V03853 V04242 V01919 V01236 V03187 V03698 V03825 V01389 V02398 V02129 V03382 V03055 V02195 V02201 V02097 V02093 V02085…
FDA’s list runs to 12,469 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) and internationally to Argentina, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Canada, Chile, China, Columbia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macau, Malaysia, Mexico, Moldova, Montenegro, Netherlands, New Zealand, Nigeria, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Republic and Venezuela.
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.
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 Jan 30, 2017.
- FDA classified it on Mar 1, 2017.
- FDA’s Enforcement Report published it on Mar 8, 2017.
- FDA terminated it on Aug 19, 2017.
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 12,469 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.