Lifescan Inc OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07, 020-244-07, 020-963-01) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07, 020-244-07, 020-963-01)
Brand
Lifescan Inc
Lot Codes / Batch Numbers
Part numbers 020-245-07 (100 pack), 020-244-07 (50 pack), 020-963-01 (50 pack mail order). Expiration dates 08/2007 through 11/2008.
Products Sold
Part numbers 020-245-07 (100 pack), 020-244-07 (50 pack), 020-963-01 (50 pack mail order). Expiration dates 08/2007 through 11/2008.
Lifescan Inc is recalling OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: due to Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings.
Recommended Action
Per FDA guidance
March 2007 via letters to consumers and consignees and web postings. The firm has also set up verbal communication plans for customers who contact Lifescan by phone.
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