ARCHITECT MAGNESIUM, (a)
Medical device recall Z-0971-2019. Published in FDA’s Enforcement Report on Mar 13, 2019.
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 13, 2019. 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
- 24,995 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?
Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias specification and demonstrate depressed recovery of up to 37%. The specific cause of the negative bias/depressed results is currently under investigation.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.
24,995 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(a) 7D70 21 Lot Number UDI Number 36338UN17 (01)00380740012922(17)190106(10)36338UN17 79865UN17 (01)00380740012922(17)190309(10)79865UN17 12921UN17 (01)00380740012922(17)190503(10)12921UN17 43618UN17…
Every code shown here, 1,605 characters
(a) 7D70 21 Lot Number UDI Number 36338UN17 (01)00380740012922(17)190106(10)36338UN17 79865UN17 (01)00380740012922(17)190309(10)79865UN17 12921UN17 (01)00380740012922(17)190503(10)12921UN17 43618UN17 (01)00380740012922(17)190609(10)43618UN17 45337UN17 (01)00380740012922(17)190714(10)45337UN17 84994UN17 (01)00380740012922(17)191012(10)84994UN17 24856UN17 (01)00380740012922(17)191113(10)24856UN17 41652UN18 (01)00380740012922(17)200120(10)41652UN18 99639UN18 (01)00380740012922(17)200226(10)99639UN18 99661UN18 (01)00380740012922(17)200413(10)99661UN18 78493UN18 (01)00380740012922(17)200725(10)78493UN18 95220UN18 (01)00380740012922(17)200907(10)95220UN18 31428UN18 (01)00380740012922(17)201031(10)31428UN18 33784UN18 (01)00380740012922(17)200611(10)33784UN18 (b) 7D70-31 36339UN17 (01)00380740012939(17)190106(10)36339UN17 97389UN17 (01)00380740012939(17)190309(10)97389UN17 12922UN17 (01)00380740012939(17)190503(10)12922UN17 43616UN17 (01)00380740012939(17)190609(10)43616UN17 45338UN17 (01)00380740012939(17)190714(10)45338UN17 84993UN17 (01)00380740012939(17)190901(10)84993UN17 08788UN17 (01)00380740012939(17)191012(10)08788UN17 24857UN17 (01)00380740012939(17)191113(10)24857UN17 41651UN18 (01)00380740012939(17)200129(10)41651UN18 99640UN18 (01)00380740012939(17)200226(10)99640UN18 99662UN18 (01)00380740012939(17)200413(10)99662UN18 33783UN18 (01)00380740012939(17)200509(10)33783UN18 33785UN18 (01)00380740012939(17)200611(10)33785UN18 78859UN18 (01)00380740012939(17)200725(10)78859UN18 95341UN18 (01)00380740012939(17)200907(10)95341UN18 31429UN18 (01)00380740012939(17)201031(10)31429UN18
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 to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR.
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 2, 2019.
- FDA classified it on Mar 1, 2019.
- FDA’s Enforcement Report published it on Mar 13, 2019.
- FDA terminated it on Jun 30, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abbott Laboratories, Inc, of Irving, TX.
- 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.”
- 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.