Recall Z-0971-2019 ยท JGJ Photometric Method, Magnesium
Abbott Laboratories, Inc
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.
| Date | Jan 2, 2019 |
| 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. |
| Root cause | Under Investigation by firm |
| Action | The firm, Abbott, initiated the recall by letter on 01/02/2018 titled '"Product Correction Urgent-Immediate Action Required" by its customers. The letter explained the issue, described the product and actions to be taken. The customers were instructed to do the following: -Immediately discontinue use of the ARCHITECT Magnesium (LN 7D70) urine application. - You may continue to use the serum/plasma application for the ARCHITECT Magnesium (LN 7D70). -Please review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing |
| Quantity | 24,995 units |
| Distribution | Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981791 | MG Abbott Laboratories, Oct 23, 1998 |