FDA Device

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

Hazard

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

What You Should Do

Remedy

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.

Products

Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. Model numbers: 99120-01
Brand
Abbott Laboratories
UPC
Lot Numbers: 3098, 3099, 3100

Units Affected

4708 units