—#48915

Product

Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. Model numbers: 99120-01

FDA product code: KRY — Calibrator For Platelet Counting
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K902892
Affected lot / code info: Lot Numbers: 3098, 3099, 3100

Why it was recalled

Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results.

Root cause (FDA determination)

Other

Action the firm took

The firm notified its consignees via customer letter sent on 09/18/2006, with information regarding the recall, requesting reply via a form included in the letter.

Recalling firm

Firm: Abbott Laboratories
Address: 5440 Patrick Henry Dr, Santa Clara, California 95054-1113

Distribution

Distribution pattern: Worldwide, including USA, Costa Rica, Columbia, Ecuador, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, El Salvador, Germany, Japan, Philippines, Singapore, Hong Kong/China, Taiwan, Thailand, Malaysia, South Korea, Australia, New Zealand, Honduras, Nicaragua, Haiti, Bermuda, Virgin Islands, Panama, St. Eustatius, and St. Martin.

Timeline

Recall initiated: 2006-09-18
Posted by FDA: 2006-12-05
Terminated: 2007-11-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48915. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.