CLASS II Device recall · Reported 1 Apr 2020 · FDA Enforcement Report
Precision Xtra Blood Glucose & Ketone Monitoring System recalled
Abbott Diabetes Care is recalling Precision Xtra Blood Glucose & Ketone Monitoring System, distributed in 32 states. The recall was initiated on 14 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1556-2020
- FDA event ID
- 84866
- Recalling firm
- Abbott Diabetes Care, Alameda, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Nov 2019
- FDA classified
- 23 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 14 Nov 2019 | Recall initiated by company | |
| 23 Mar 2020 | Classified by FDA | +130 days |
| 1 Apr 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.
Product as listed by the FDA
Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
Where it was distributed
U.S.: KY, NY, TN, MA, IL, SC, VT, FL, CA, NC, MS, NJ, TX, AL, GA, OK, CT, PA, NE, ND, MT, MO, DC, ME, LA, KS, ID, OH, MN, NM, VA, IN
AlabamaCaliforniaConnecticutDistrict of ColumbiaFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaineMinnesotaMissouriMississippiMontanaNorth CarolinaNorth Dakota
Questions about this recall
Why was it recalled?
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.
Which lots are affected?
Not associated with specific model/lot numbers.
Where was it sold?
U.S.: KY, NY, TN, MA, IL, SC, VT, FL, CA, NC, MS, NJ, TX, AL, GA, OK, CT, PA, NE, ND, MT, MO, DC, ME, LA, KS, ID, OH, MN, NM, VA, IN
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 84866| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Optium EZ Blood Glucose Monitoring System recalled | Abbott Diabetes Care | Other | 32 states | |
| CLASS II | FreeStyle Precision H Blood Glucose and Ketone Monitoring System recalled | Abbott Diabetes Care | Other | 32 states |
More recalls from Abbott Diabetes Care
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | FreeStyle Libre 3 App, part of Continuous Glucose recalled | Abbott Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS II | FreeStyle Libre 2 Readers recalled by Abbott Diabetes Care | Abbott Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS I | FreeStyle Libre Reader recalled by Abbott Diabetes Care | Abbott Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS I | FreeStyle Libre Reader recalled by Abbott Diabetes Care | Abbott Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS I | FreeStyle Libre Reader recalled by Abbott Diabetes Care | Abbott Diabetes Care | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Device Malfunction | CA |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Packaging Defects | Nationwide |