True Metrix Blood Glucose Monitoring Systems Recall — Provider Guidance
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Notice to Kentucky Medicaid providers about a Class I recall and labeling correction for TRUE METRIX family blood glucose monitoring systems; directs providers on patient counseling, temporary replacement supplies, and where to report adverse events.
No material clinical or coverage changes in this revision.
Provider Guidance and Coverage Actions
Provider actions during recall
Recommended actions for providers caring for patients using TRUE METRIX devices:
Supported by Trividia/FDA recall notice and MedImpact provider recommendations.
Trividia has a third‑party distribution program that can send a temporary replacement meter and 50 test strips to patients.
Updated labeling clarifies E-5 can indicate >600 mg/dL or a strip error and emphasizes immediate medical attention if symptomatic.
The manufacturer has not provided a comprehensive NDC list beyond the specific affected NDCs published in the recall notice. The notice therefore lists the TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO products that may be impacted and their associated NDCs rather than supplying a separate master exclusion list. No additional exclusions or coverage limitations are stated in the notice.
Affected Codes and Coding Details
| 11917017389 | True Metrix Air Glucose meter NDC listed in recall notice |
| 56151149002 | True Metrix Air Glucose meter NDC listed in recall notice |
| 56151149102 | True Metrix Air Glucose meter NDC listed in recall notice |
| 56151149403 | True Metrix Air Glucose meter NDC listed in recall notice |
| 87701042739 | True Metrix Air Glucose meter NDC listed in recall notice |
| 56151149401 | True Metrix Air Glucose meter NDC listed in recall notice |
| 08528147401 | True Metrix Blood Glucose meter NDC listed in recall notice |
| 21292000605 | True Metrix Blood Glucose meter NDC listed in recall notice |
| 56151147002 | True Metrix Blood Glucose meter NDC listed in recall notice |
| 87701042625 | True Metrix Blood Glucose meter NDC listed in recall notice |
Operational Steps for Providers
Prior authorization contact points — no change to prior auth policy
For prior authorization questions related to Kentucky Medicaid, use the Kentucky MCO or FFS contact points provided; this notice does not change prior authorization policy for diabetic supplies.
- KY MCO Prior Authorizations: Phone (844) 336-2676 [8:00AM - 7:00PM EST/7 days]; Fax (858) 357-2612; Pharmacy Help Desk: (800) 210-7628 (24/7); Portal: https://kyportal.medimpact.com/.
- KY FFS Prior Authorizations: Phone (877) 403-6034 [8:00AM - 7:00PM EST/7 days]; Pharmacy Help Desk: (877) 403-6034 (24/7); Portal: https://kyportal.medimpact.com/.
No step therapy required; advise transition to alternatives
There are no step therapy requirements specified in the notice; providers are instructed to transition patients to alternative blood glucose testing methods when possible until corrected meters are available.
- Users should continue testing and should not stop using their TRUE METRIX meter until an alternative is available.
- Transition patients to alternative testing methods if possible until corrected meters are available.
Document and notify patients and facilities of the recall
Inform patients immediately about the recall and updated E-5 error code instructions, and post the 'URGENT MEDICAL DEVICE CORRECTION' HCP notice in areas where products are stored; provide Trividia contact information for adverse events or questions.
- Instruct patients to follow the updated E-5 guidance or visit www.trividiahealth.com for Owner's Booklets and resources.
- For facilities: post the 'URGENT MEDICAL DEVICE CORRECTION' HCP notice where products are stored.
- Trividia contact for questions or adverse reactions: trividia0126CC@trividiahealth.com or 1-888-835-2723; consumer support 1-800-803-6025 (Mon–Fri, 8 AM–8 PM EST).
Billing and coverage — no explicit denials stated
The notice does not state any explicit billing or coverage denials; guidance centers on transitioning patients to alternative glucose testing and continuing testing until alternatives are available.
- No explicit billing or coverage denials are provided in the recall communication.
- Focus is on patient transition to alternative testing and ensuring ongoing glucose monitoring until replacements are accessible.
Device Background and Recall Summary
The TRUE METRIX family of blood glucose meters can display an E-5 error, which may indicate either a test strip error or a very high blood glucose level (typically >600 mg/dL). The manufacturer has updated device labeling to emphasize that users who receive an E-5 error and who are experiencing symptoms of hyperglycemia should seek immediate medical attention. Providers should be aware that incorrect prior instructions could delay urgent care for symptomatic hyperglycemia, increasing risk of dehydration, altered mental status, or worse.
Key Terms and Device Messages
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