9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium,…
Medical device recall Z-1098-2021. Published in FDA’s Enforcement Report on Feb 17, 2021.
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 Feb 17, 2021. 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
- 1,214 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?
May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit for iCa++ is set to mg/dL (configured as Service Code MGL) and a measured iCa++ value is lower than the normal range, an upward arrow is shown on the display instead of a downward arrow. The display is set per default to mmol/L; therefore, the arrow indicating an alarm reflects normal ranges of iCa++ in mmol/L. If mg/dL is chosen, the arrow warnings on screen still reflect the ranges from mmol/L, rather than mg/dL. The numeric result is displayed correctly.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the whole blood, serum or plasma, urine, dialysate solutions, or QC materials. catalog number 03157334001 . in vitro diagnostic use.
1,214 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All Serial Numbers: U18.5093 U18.2418 U18.1099 U18.4188 U18.2819 13002 U18.3698 U18.4498 U18.3629 U18.3056 U18.3058 U18.2954 U18.4423 U18.4584 17769 U18.3657 U18.2026 U18.2245 13982 U18.2839 7148 7151 15061 27989 7143 U18.3533 U18.3590…
Every code shown here, 1,997 characters
All Serial Numbers: U18.5093 U18.2418 U18.1099 U18.4188 U18.2819 13002 U18.3698 U18.4498 U18.3629 U18.3056 U18.3058 U18.2954 U18.4423 U18.4584 17769 U18.3657 U18.2026 U18.2245 13982 U18.2839 7148 7151 15061 27989 7143 U18.3533 U18.3590 U18.6311 U18.5772 5925 U18.5230 6265 U18.4798 U18.1900 17760 U18.3447 7157 U18.5809 U18.4696 U18.4698 19313 U18.3216 U18.3259 U18.3599 12853 U18.2144 U18.3519 U18.6131 U18.3648 U18.2430 U18.1138 U18.3137 U18.2334 U18.2972 U18.1554 U18.3537 U18.4440 U18.1160 U18.4014 U18.3324 U18.2006 24119 U18.3717 U18.1175 U18.1555 U18.4181 U18.2070 U18.6807 U18.2725 U18.1173 15217 U18.2172 U18.2727 U18.4357 U18.2441 15408 16650 22334 22336 U18.2277 U18.3052 U18.2110 U18.4254 U18.5501 U18.4755 U18.4230 U18.4365 U18.3638 U18.3089 15071 U18.3215 6836 6841 18016 U18.3789 U18.4243 U18.5644 U18.6395 U18.3390 U18.6644 U18.2679 U18.3096 U18.3064 U18.3635 12879 U18.3745 19537 17151 U18.4431 U18.3279 U18.4330 27753 19581 U18.2350 U18.4265 U18.1498 13667 U18.2828 U18.3384 25517 13983 13762 14981 15409 17202 14732 26969 U18.2946 U18.2789 U18.1461 U18.2593 U18.3397 U18.1772 U18.1777 U18.7156 U18.5830 U18.3613 12405 U18.4385 U18.3414 U18.1678 U18.5922 6981 U18.2814 U18.4750 U18.3604 19562 24115 U18.2797 U18.1341 26424 26738 U18.1563 U18.4017 U18.2850 U18.3051 U18.3675 U18.2865 U18.5261 U18.3449 U18.1504 U18.2420 U18.4208 6263 U18.2816 U18.4260 U18.2249 17422 U18.4198 U18.6258 U18.5085 15804 U18.7177 U18.4315 U18.1334 U18.3794 14544 U18.3799 U18.2238 12824 6642 19626 25519 U18.2504 U18.2276 U18.1072 23712 A18.12710 U18.2849 24629 U18.2514 U18.3536 U18.2020 U18.4867 U18.2438 U18.2808 U18.3018 16509 U18.1323 12924 14567 21847 U18.2422 U18.1130 U18.1177 7145 U18.3522 U18.3133 U18.3487 U18.4223 A18.12282 7154 12812 U18.1345 14309 U18.1109 U18.6309 U18.2248 U18.1193 U18.3715 U18.3298 U18.2013 U18.2341 U18.4215 U18.1783 U18.3193 U18.3670 U18.2825 12375 U18.1740 U18.4382 U18.6393 U18.3545 6838 U18.4199 U18.2551 U18.2553 U18.4506 U18.2452 U18.2591 15418 U18.4592 19106…
FDA’s list runs to 9,711 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 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 Jan 6, 2021.
- FDA classified it on Feb 8, 2021.
- FDA’s Enforcement Report published it on Feb 17, 2021.
- FDA terminated it on Feb 28, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Roche Diagnostics Operations, Inc., of Indianapolis, IN.
- 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 9,711 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.