Access 2 Immunoassay Analyzer
Medical device recall Z-1386-2025. Published in FDA’s Enforcement Report on Mar 26, 2025.
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 26, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 873 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 identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Access 2 Immunoassay Analyzer, Catalog Number 81600N
873 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 15099590265380; Serial Numbers: 574626 574627 574839 574840 574841 574842 574852 574853 574854 574378 573724 574432 574538 574907 574497 574303 574184 574218 574219 574305 574332 574333 574345 574346 574414 574451 574581 574582…
Every code shown here, 2,000 characters
UDI-DI: 15099590265380; Serial Numbers: 574626 574627 574839 574840 574841 574842 574852 574853 574854 574378 573724 574432 574538 574907 574497 574303 574184 574218 574219 574305 574332 574333 574345 574346 574414 574451 574581 574582 574583 574584 574726 574727 574728 574729 574730 574731 574732 574733 574920 574922 574923 574955 574957 574958 574959 574984 574985 574986 574987 574811 574160 574161 574167 574168 574169 574171 574177 574178 574179 574180 574182 574230 574297 574300 574465 574466 574467 574468 574615 574735 574807 574858 574887 574893 574896 574912 574913 574925 574926 574950 574952 574979 574982 573109 573073 573072 574585 574586 574587 574588 574589 574590 574172 574173 574174 574175 574181 574183 574224 574227 574238 574239 574244 574245 574253 574254 574256 574258 574259 574267 574268 574269 574270 574271 574284 574295 574296 574313 574335 574336 574338 574392 574393 574394 574395 574396 574397 574398 574399 574400 574402 574403 574404 574405 574406 574407 574520 574536 574576 574577 574578 574579 574580 574591 574616 574618 574619 574620 574621 574675 574676 574677 574678 574681 574682 574683 574684 574685 574741 574829 574830 574831 574832 574865 574866 574867 574869 574879 574880 574881 571672 510520 512247 573221 575002 574225 574401 574194 574199 574371 574773 574774 574093 574094 574129 574202 574204 574211 574252 574257 574352 574201 574251 574261 574369 574476 574478 574495 574628 509167 570853 574330 574331 574469 574470 574471 574209 574213 574290 574340 574686 574864 574899 573514 570759 574547 574929 574212 574215 574897 574680 574799 574223 574205 574206 574231 574235 574237 574240 574241 574248 574249 574250 574260 574262 574263 574264 574265 574266 574273 574274 574282 574285 574293 574294 574306 574318 574319 574320 574321 574322 574327 574328 574329 574348 574349 574350 574351 574353 574373 574374 574375 574376 574377 574384 574385 574386 574387 574388 574415 574418 574419 574420 574421 574454 574455 574456 574457 574458 574479…
FDA’s list runs to 6,150 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 - US Nationwide 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.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 5, 2025.
- FDA classified it on Mar 17, 2025.
- FDA’s Enforcement Report published it on Mar 26, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Beckman Coulter, Inc., of Chaska, MN.
- 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 6,150 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.