Lower riskMedical device recall · FDA · Published January 2, 2019
Abbott ARCHITECT Magnesium Test Kits May Give Low Results
Abbott recalls specific ARCHITECT Magnesium test kits that may give inaccurate low results for magnesium in urine. Affected kits have lot numbers listed in the recall notice.
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.
Take action
Contact the company
📍Recalling firmAbbott Laboratories, Inc1921 Hurd Dr · Irving, TX 75038-4313
“Abbott ARCHITECT Magnesium Test Kits May Give Low Results.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69194-abbott-architect-magnesium-test-kits-may-give-low-results. Based on FDA recall #Z-0971-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0971-2019%22&limit=1).
The FDA announced on Jan. 2, 2019, that Abbott Laboratories is recalling ARCHITECT MAGNESIUM assays because internal testing found depressed urine result recovery. The agency classified the recall as Class II.
How to tell if you have it
Brand: Abbott
Product: ARCHITECT MAGNESIUM
REF: 7D70-21, 7D70-31
UPC: 00380740012922, 00380740012939
Units affected: 24,995
The hazard
Abbott internal testing identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples greater than 0.5mEq/L fail linearity acceptance criteria for bias specification and show depressed recovery of up to 37%.
Context
GovInfoNow's records show Abbott Laboratories has had 11 other recalls since Sept. 29, 2017. Other recent recalls include the Abbott Alinity s System Software Version 2.8.0 Recall (Feb. 3, 2022), the Abbott Alinity s System Recall (July 12, 2021), and the Abbott ARCHITECT C System Mixer Recall (May 1, 2019). Other recent recalls of similar products include the Siemens Atellica CH Urine Albumin Recall (July 6, 2026) and the Sperm Ab ELISA Test Kit Recall (July 2, 2026).
How to tell if you have this one
Check the lot numbers on the test kit packaging. Affected kits have specific lot numbers listed in the recall notice, such as 36338UN17 or 97389UN17.
Brand
Abbott
Product
ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the lot number on the test kit packaging, which should match the numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0971-2019 (January 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0971-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.