Z-0246-2007

Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems...

Name: Z-0246-2007 Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems...
Creator: Abbott Laboratories
Published: 2006-09-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-09-18 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. Model numbers: 99120-01 on 2006-09-18. The reason FDA records is "Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0246-2007
Status: Terminated
Initiated: 2006-09-18
Posted: 2006-12-05
Terminated: 2007-11-28
Recalling firm: Abbott Medical
Product: Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. Model numbers: 99120-01
Product code: KRY Calibrator For Platelet Counting
Reason for recall: Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results.
Root cause tag: manufacturing process
FDA root cause: Other
Action: 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.
Quantity in commerce: 4708 units
Distribution: 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.
Product codes and lots: Lot Numbers: 3098, 3099, 3100

Product code KRY

K902892Class IICell-Dyn CalibratorUnipath , Ltd. / cleared 1990-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)