Lifescan Inc LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037
Brand
Lifescan Inc
Lot Codes / Batch Numbers
OneTouch Ultra Test Strip Lot: 1022859, exclusively in Italy.]
Products Sold
OneTouch Ultra Test Strip Lot: 1022859; [A second lot (# 1022865) was also mislabeled with the incorrect Control Solution range. This lot was distributed outside of the US, exclusively in Italy.]
Lifescan Inc is recalling LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-0 due to A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.
Recommended Action
Per FDA guidance
On 11/17/03 the firm initiated the recall and their notification was via letters informing its customers of the removal.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026