Z-0971-2019Class II

ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of...

Name: Z-0971-2019 ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of...
Creator: Abbott Laboratories, Inc
Published: 2019-01-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-01-02 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of 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 on 2019-01-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0971-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-02
Posted: 2019-03-01
Terminated: 2021-06-30
Recalling firm: Abbott Medical
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.
Product code: JGJ Photometric Method, Magnesium
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.
FDA 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 previously reported patient results. -Complete and return the Customer Reply Form prior to January 17, 2019 via FAX #: 18007770051 or email [email protected]. Even if you no longer have the instrument(s),. -If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. -As an alternative to the current urine application, you may use Abbott ARCHITECT (enzymatic) Magnesium LN 3P68, urine application, where available. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
Quantity in commerce: 24,995 units
Distribution: Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR.
Product codes and lots: (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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0971-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0971-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-13	2019-03-01

Product code JGJ

K981791Class IMgAbbott Laboratories / cleared 1998-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)