BioPlex 2200 CMV IgM Reagent Pack Recalled for Variable Test Performance
Bio-Rad Laboratories recalls the BioPlex 2200 ToRC IgM Reagent Pack (Lot 301388) due to CMV IgM analyte showing variable elevated background levels depending on reagent handling.
What this means for you
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: FDA Class II recall involving a diagnostic reagent with analytical performance concerns affecting CMV IgM test reliability. No illnesses or injuries have been reported, making this a risk-of-harm situation with theoretical rather than documented patient harm.
Plain-English summary
Bio-Rad Laboratories, Inc. is recalling the BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack (Lot Number 301388) due to performance concerns with the CMV IgM analyte. The reagent pack has demonstrated variable elevated background levels in CMV IgM test results depending on how the reagent was handled.
The recalled reagent packs were distributed worldwide. In the United States, distribution included the states of Arkansas, Arizona, California, Florida, Hawaii, Iowa, Illinois, Michigan, Minnesota, Nebraska, New York, Tennessee, Texas, and Washington. International distribution included the Czech Republic, France, Germany, and Italy. A total of 348 units were distributed.
Healthcare providers using these reagent packs should discontinue use of Lot 301388 and contact Bio-Rad Laboratories for replacement stock. The variable test results could affect the accuracy of CMV IgM diagnostic testing. Patients who may have received testing with this lot should consult their healthcare provider for guidance.
The recalled product
- Product
- BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
- Manufacturer
- Bio-Rad Laboratories, Inc.
- Hazard
- analytical-performance-issue
- test-inaccuracy
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01