LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by LifeScan, Inc., 1000
FDA device recall Z-1596-05 · posted 2005-09-29 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- LifeScan brand OneTouch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)--mg/dL versus mmol/L. This error has the potential to lead to acute hyperglycemic complications if the user fails to realize that 18mg/dL of glucose is equal to 1 (one) mmol/L.
- Action taken
- Firm contacted all accounts by letters of 11/21/03, 2/4/2004, 2/17/04 and 2/9-10/2004 providing important information regarding the owner''s booklet.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- Approximately 572,000 units
- Distribution
- The recall product was distributed in the U.S. only. LifeScan manufactured and distributed OneTouch Ultra System Kits with the affected OneTouch Ultra Meter Owner''s Booklets between March 31, 2003 an
- Date initiated
- 2003-11-21
- Date posted
- 2005-09-29
- Date terminated
- 2005-11-29
- Location
- Milpitas, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS (K024194) | Lifescan, Inc. | 2003-02-07 |