Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 13, 2019
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.
Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance crite…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Abbott Laboratories, Inc recalled ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the … - a moderate-severity action.
ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the … was recalled by Abbott Laboratories, Inc in March 13, 2019. Reason: Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine resu…. Check the official notice for the remedy. Verify recall #Z-0971-2019 with the FDA Devices before acting.
The recall
Abbott Laboratories, Inc issued this moderate-severity FDA Devices recall-Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine resu….
- Moderate
- severity level
- 25K units
- affected scope
- Class II
- classification
- March 13, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0971-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0971-2019) was formally reported on March 13, 2019, with the manufacturer initiating the action on January 2, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Abbott Laboratories, Inc is listed as the recalling firm, operating out of Irving, TX. Federal records list the affected scope as 24,995 units.
The documented reason for this recall is: 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 demon… Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
24,995 units
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0971-2019 |
| Date reported | March 13, 2019 |
| Date initiated | January 2, 2019 |
| Recalling firm | Abbott Laboratories, Inc |
| Firm location | Irving, TX |
| Affected scope | 24,995 units |
| Distribution | Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0971-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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.. Recalled by Abbott Laboratories, Inc. Units affected: 24,995 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2019. Severity: Moderate. Recall number: Z-0971-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0971-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 13, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.