Z-0501-2007

IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody...

Name: Z-0501-2007 IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody...
Creator: Abbott Laboratories MPG
Published: 2006-08-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-08-11 / Terminated

FDA source

Abbott Laboratories MPG began a recall of IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus... on 2006-08-11. The reason FDA records is "The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0501-2007
Status: Terminated
Initiated: 2006-08-11
Posted: 2007-02-15
Terminated: 2008-01-18
Recalling firm: Abbott Medical
Product: IMx Sirolimus Reagent Pack; list 5C91-21; 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
Product code: NRP Sirolimus Test System
Reason for recall: The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens.
FDA root cause: Other
Action: Abbott initiated a field correction recall by letter dated 8/11/06 to all customers receiving the affected reagent. The accounts were informed of the shift in sample values after storage at 2-8*C or with freeze thaw of specimens with the affected lots of reagents. The accounts were requested to review the revised sample handling information included in the attachment to the letter with their laboratory personnel and retain a copy of the letter and attachment for their records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.
Quantity in commerce: 2,800 kits
Distribution: Worldwide, including USA, Puerto Rico, Poland, Croatia, Latvia, Estonia, Serbia & Montenegro, Japan, Turkey, Singapore, China, India, Taiwan, Thailand, South Africa, South Korea, Australia, New Zealand, Norway, Italy, Portugal, Spain, Greece, Panama, Hungary, Slovakia, Russia, Romania, Cyprus, Germany, Lithuania, Saudi Arabia, Jordan, Israel, Lebanon, Kuwait, Oman, Qatar, UAE, Egypt, Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Argentina, Brazil, El Salvador, Canada, Ireland, United Kingdom, Sweden, Netherlands, Belgium, France, Austria, Czech Republic, and Switzerland
Product codes and lots: list 5C91-21, lots 053389, 053457, 063650, 063973, 064459, 064772, 064750, 065076

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)