Z-1355-2019Class III

ARCHITECT Sirolimus Calibrators -

Name: Z-1355-2019 ARCHITECT Sirolimus Calibrators -
Creator: Abbott Laboratories
Published: 2019-04-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-04-09 / Terminated

FDA source

Abbott Laboratories began a recall of ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the... on 2019-04-09. FDA classified it as Class III and gives the reason as "Devices were delivered without the required dry ice". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1355-2019
Classification: Class III
Status: Terminated
Initiated: 2019-04-09
Posted: 2019-05-16
Terminated: 2019-12-20
Recalling firm: Abbott Medical
Product: ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.
Product code: JIT Calibrator, Secondary
Reason for recall: Devices were delivered without the required dry ice.
FDA root cause: Under Investigation by firm
Action: On about 04/04/2019, Abbott notified customers in Latvia of the recall. Instructions included to examine inventory for any affected devices on hand, review the 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, and notify customers if the affected devices have been forwarded to other laboratories and provide them a copy of the notification letter. If replacement material is available, customers were instructed to discontinue the use of affected devices and destroy any remaining inventory according to your laboratory procedures. If replacement material is not available, immediately order replacement material. Abbott instructed customers that they may continue to use the impacted material as long as controls are within range. Destroy impacted material once replacement material is available.
Quantity in commerce: 1 unit
Distribution: Distribution to Latvia.
Product codes and lots: LN 1L76-01; Lot 46K15718

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1355-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1355-2019	Class III	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-16
Z-1356-2019	Class III	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-16
Z-1357-2019	Class III	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-16
Z-1358-2019	Class III	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-16
Z-1359-2019	Class III	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-16
Z-1360-2019	Class III	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-16
Z-1361-2019	Class III	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-16
Z-1362-2019	Class III	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-16
Z-1363-2019	Class III	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-16

Product code JIT

K070822Class IIArchitect Sirolimus AssayFujirebio Diagnostics,Inc. / cleared 2007-09-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)