Abbott Laboratories MPG 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Abbott Laboratories MPG
Lot Codes / Batch Numbers
list 5C91-21, lots 053389, 053457, 063650, 063973, 064459, 064772, 064750, 065076
Products Sold
list 5C91-21, lots 053389, 053457, 063650, 063973, 064459, 064772, 064750, 065076
Abbott Laboratories MPG is recalling IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus due to The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026