Tacrolimus Calibrator Set Recalled for Inaccurate Immunoassay Quantitation
The QMS Tacrolimus Calibrator Set is recalled because calibrators recovered 82-94% of target values, causing inaccurate (over-quantitated) patient drug test results. This affects healthcare facilities in 20 US states and 9 countries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device with documented calibration error affecting tacrolimus quantitation in transplant patients. No adverse events reported, but meets the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Microgenics Corporation is recalling the QMS Tacrolimus Immunoassay Calibrator Set REF 10015573, which consists of six calibrators (A through F). A total of 615 kits have been distributed across the United States, Bangladesh, Brazil, Canada, Germany, India, Malaysia, Mexico, South Korea, and Thailand.
The calibrators recovered between 82 and 94 percent of their target values. This malfunction results in over-quantitation in tacrolimus patient result values when the calibrators are used with the QMS Tacrolimus Immunoassay system. Tacrolimus is an immunosuppressant medication used in transplant patients, and accurate quantitation is critical for safe dosing.
In the United States, affected facilities are located in Alabama, Arizona, California, District of Columbia, Florida, Iowa, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia.
Healthcare facilities that have received affected lots 74175462 or 74267412 should stop using these calibrators immediately and contact Microgenics Corporation for replacement product. Any patient results generated with these calibrators may need to be reviewed and reanalyzed using correct calibrators.
The recalled product
- Product
- QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3
- Manufacturer
- Microgenics Corporation
- Affected units
- 615
Distribution
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