ARCHITECT MAGNESIUM — Class II medical device recall Z-0971-2019
Terminated recall by Abbott Laboratories, Inc, reported 2019-03-13, distributed nationwide. Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine resul
| Recall number | Z-0971-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Inc, Irving, TX, United States |
| Recall initiated | 2019-01-02 |
| Classified | 2019-03-01 |
| Reported by FDA | 2019-03-13 |
| Terminated | 2021-06-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, GT, SV, TH |
| Quantity | 24,995 units |
| UPC / GTIN / UDI-DI | 00380740012922, 00380740012939 |
| Lot numbers | 08788UN17, 12921UN17, 12922UN17, 24856UN17, 24857UN17, 31428UN18, 31429UN18, 33783UN18, 33784UN18, 33785UN18, 36338UN17, 36339UN17, 41651UN18, 41652UN18, 43616UN17, 43618UN17, 45337UN17, 45338UN17, 78493UN18, 78859UN18, 79865UN17, 7D70-31, 84993UN17, 84994UN17, 95220UN18, 95341UN18, 97389UN17, 99639UN18, 99640UN18, 99661UN18, 99662UN18 |
| Model numbers | 7D70-21 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0971-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.