Z-2171-2010

IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated...

Name: Z-2171-2010 IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated...
Creator: Abbott Laboratories
Published: 2010-04-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-04-30 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline... on 2010-04-30. The reason FDA records is "IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2171-2010
Status: Terminated
Initiated: 2010-04-30
Posted: 2010-08-03
Terminated: 2011-05-13
Recalling firm: Abbott Medical
Product: IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd., Dundee, UK for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA; list 5C91-21 The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy.
Product code: NRP Sirolimus Test System
Reason for recall: IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Abbott sent a "Product Recall" letter dated April 30, 2010, to all customers receiving the affected lot of reagent. The accounts were informed of the increased frequency of calibration errors, including: 157 Check 1 Out of Range, 161 Check 5 Out of Range, and 173 Mode 1 deviation Factor High. The accounts were requested to determine if they are currently using or have inventory of lot 802873106, discontinue use of and destroy any remaining inventory of the lot, and retain a copy of the letter for their laboratory records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688. Customers outside of the U.S., please contact your local Customer Service Representative.
Quantity in commerce: 466 kits
Distribution: Worldwide distribution: USA and countries including Puerto Rico, Argentina, Austria, Bahrain, Brazil, Canada, Chile, China, Croatia, Cyprus, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Lebanon, Lithuania, Netherlands, Norway, Philippines, Poland, Russia, Panama, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE and Venezuela.
Product codes and lots: Lot number 802873106, Expiry Date May13, 2010

Product code NRP

K042411Class IIAbbott Imx Sirolimus Microparticle Enzyme ImmunoassayAxis-Shield , Ltd. / cleared 2005-04-07

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)