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Terminated

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

FDA Recall Z-0246-2007 · Posted 2006-12-05

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeKRY
Date Initiated2006-09-18
Date Terminated2007-11-28
Product Quantity4708 units

Reason for Recall

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

Firm 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.

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K902892CELL-DYN CALIBRATORUnipath , Ltd. · 1990-09-10

Official Source

View FDA Recall →

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

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