Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA.

FDA Recall Z-2639-2010 · Posted 2010-10-01

Recalling FirmLifescan Inc
Recall StatusTerminated
Product CodeNBW
Date Initiated2010-01-07
Date Terminated2011-03-14
Product Quantity9631 cartons, 4 vials per carton

Reason for Recall

One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips.

Firm Action

Notification was issued by the firm during the first week of February. This letter asked consignees to share the information with patients, and are asking users to contact the firm and to examine their stock for the recalled product.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Product was distributed to one wholesale dealer and one distributor and 2 medical facilities in CA, OH and PA, as well as the UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062195MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc. · 2006-08-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑