FDA Medical Device Recalls (openFDA)
Abbott Laboratories: 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.
- Recall number
- Z-2171-2010
- Recalling firm
- Abbott Laboratories
- 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.
- Status
- Terminated
- Initiated
- 2010-04-30
- Posted
- 2010-08-03
- Terminated
- 2011-05-13
- Reason
- IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors.
- 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
- 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.
- Lot, serial or model codes
- Lot number 802873106, Expiry Date May13, 2010
- 510(k) numbers
- ["K042411"]
- PMA numbers
- not on file
- Product code
- NRP
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28