ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantita...
FDA Device Recall #Z-0971-2019 — Class II — January 2, 2019
Recall Summary
| Recall Number | Z-0971-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 2, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Abbott Laboratories, Inc |
| Location | Irving, TX |
| Product Type | Devices |
| Quantity | 24,995 units |
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR.
Lot / Code Information
(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
Other Recalls from Abbott Laboratories, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0749-2022 | Class II | Alinity s System software version2.8.0, REF LN ... | Feb 3, 2022 |
| Z-2276-2021 | Class II | Alinity s System REF 06P16-01. An automated i... | Jul 12, 2021 |
| Z-1671-2020 | Class II | ARCHITECT C System Mixer - Product Usage: The A... | May 1, 2019 |
| Z-2755-2019 | Class II | APS Accelerator modular systems, 208-230 V-, 50... | Sep 7, 2018 |
| Z-1296-2019 | Class II | Abbott ARCHITECT cSystems ICT Module, REF 09D28... | Aug 28, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.