Class II — Abbott Laboratories, Inc
| Recalling firm | ABBOTT LABORATORIES |
|---|---|
| Registered facility | View this company's 64 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | 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. |
| Quantity | 24,995 units |
| Distribution | Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR. |
| Initiated | 2019-01-02 |
| Classified | 2019-03-01 |
| Terminated | 2021-06-30 |
| Recall number | Z-0971-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Abbott Laboratories, Inc (Z-0971-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81929/
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