—#172981

Product

iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.

FDA product code: KQO — Automated Urinalysis System
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K101852
Affected lot / code info: Lot numbers beginning with lot 7212143 except for: 7212146, 7212148, 7212160, 7212162, 7212163 and 7212164.

Why it was recalled

Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.

Root cause (FDA determination)

Component change control

Action the firm took

The recalling firm issued letters dated 10/15/2018 on 10/18/2018 via email or regular mail for customers where an email was unavailable. The letter explains the issue and impact, and provides the actions the consignee is to take when using the product. The letter informed the customer they are actively working on a resolution to prevent recurrence of the issue.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Distribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, Singapore, and Taiwan.

Timeline

Recall initiated: 2018-10-18
Terminated: 2020-11-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172981. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.